Boston Scientific warns on battery issues in certain implantable defibrillators

Updated September 19, 2013, with comment from Boston Scientific.

Boston Scientific warns on batter issues in certain implantable defibrillators

Medical device maker Boston Scientific (NYSE:BSX) issued new warnings on its Cognis and Teligen implantable cardioverter defibrillators, advising physicians to watch out for premature battery depletion in older models.

The problematic implants are no longer available and haven’t been manufactured since December 2009, according to a physician letter, but the devices may be subject a component issue that may diminish device performance after as little as 2 years, eventually depleting the battery entirely. All cases reported thus far have been detected by the implants’ on-board diagnostic tools before the patients have experienced any symptoms, Boston Scientific said.

"There have been no reported deaths associated with this issue," a company spokesman told "Boston Scientific has voluntarily notified the FDA and is alerting physicians of the issue. There are no additional clinical recommendations beyond the current standard of patient care and normal device monitoring, described in the device labeling."

The Massachusetts medical device giant asked physicians to continue normal patient care and observation and to take greater care with any alerts that pop up during routine monitoring. If the device does issue an alert, the usual 3-month window for replacement may be cut short by battery depletion, leading to poor device performance, the letter states.

The older model Cognis and Teligen devices have not been available for implant since November 2010, but there were an estimated 38,500 devices distributed that were found to be subject to higher than expected rates of malfunction (about 0.7%, or 1 in 150), according to a warning posted by China’s Dept. of Health.

Patients were warned to keep an ear out for any beeping from the implanted device, as the on-board Security Architecture system will raise an audible alarm if it detects battery issues, according to a notice from Australia’s Therapeutic Good Administration.

The new warnings are not the 1st time Boston Scientific has had issues with the Teligen and Cognis suite of devices. In April 2012 the device maker warned that 1 patient had died and others had suffered adverse events due to electrical malfunctions in the implants that the company called "an identifiable pattern of malfunction". Boston Scientific also warned on the devices in December 2009, citing connection problems on pacemakers implanted beneath the pectoral muscles. Another warning issued in March 2009 advised doctors to watch out for “inappropriate” shocks caused by faulty wiring in some of the devices.

Boston Scientific did not immediately respond to a request for comment.

RSS From Medical Design & Outsourcing

  • GlobTek presents its latest level VI AC/DC adapter and connverter
    T-43086-WWVV-X.X-Q Model is an addition to GlobTek’s Level VI compliant GT-43086 family and represents GlobTek’s 6 Watt wall plug-in series of AC/DC adapters (power supplies and chargers) with International Interchangeable blades. GlobTek’s changeable input blade system with individual field replaceable input plugs, including: North America and Japan NEMA 1-15P, Australian, UK BS 1363, European CEE […]
  • Sanmina’s familiarity with FDA gets skin treatment product to market fast
    The medical market for cosmetic devices is booming. However, quickly launching new products to meet demand is becoming more challenging because device manufactures face increased regulatory scrutiny. To help meet regulatory requirements, aesthetic and other medical-device OEMs are partnering with electronics manufacturing services (EMS) companies that also offer expertise with the FDA filings necessary to […]
  • Fluid connectors and quick disconnects for IVD equipment from CPC
    Colder Products Company (CPC) offers thousands of tubing connectors, quick disconnects and fittings for smart fluid handling in IVD and analytical equipment. Non-spill connectors speed testing throughput by eliminating drips, preventing air inclusion and increasing operator safety. Panel mount connectors can be added to existing equipment or bottle caps to provide secure, leak-free connections. Puncture […]
  • 310 Watt desktop medical power supply meets efficiency level VI requirements
    Power Partners releases a new 310 Watt medical grade desktop power supply from their PEAMD Series of AC and DC adapters. The 310 Watt unit is packed for ideal performance inside a compact case measuring 7.8 x 4 x 2 in. with a weight of only 3 lbs. The PEAMD310 Series is approved to the latest […]
  • Saelig introduces Multiple Instrument System MIS4 universal test system
    Saelig Company has introduced the ABI Electronics’ Multiple Instrument Station MIS4, an all-in-one testing tool that provides all commonly required test instruments in one compact programmable hardware module, mounted in a compact case or installed in a PC-drive bay. Controlled by ABI’s sophisticated SYSTEM 8 Ultimate PC software with a simple yet programmable operator interface, […]
  • AssurX announces document management software update for small to mid-size companies in FDA regulated industries
    AssurX, an enterprise quality management, risk and regulatory compliance solution provider, announces the release of the latest update to their AssurX document management software. The document management solution provides a cost-effective solution for small to medium sized companies faced with streamlined operations and is fully compliant for FDA regulated industries. Ideal solution for small to […]
  • Saelig presents new Amplicon Impact-R 1100F series computer
    Saelig Company announces the Amplicon Impact-R 1100F series, a fanless system powered by the Intel ATOM D2550 processor. Configured with a high performance 2.5 in. MLC Solid State Drive (SSD), the Impact-R 1100F series is a silent controller system. With options for multiple serial communication ports, the Impact-R 1100F can offer up seven DB9 connections […]
  • Gerresheimer to acquire Centor
    Gerresheimer AG, a partner to the global pharmacy and healthcare industry, will further extend its pharmaceutical packaging business with the acquisition of Centor. Gerresheimer has reached an agreement with Nemera Development S.A. to acquire 100% of the share capital of Centor US Holding. “Centor is the highly profitable market leader for plastic vials and closures in […]
  • Methods Machine Tools presents the new Nakamura-Tome NTRX-300
    Methods Machine Tools, a developer of precision machine tools and automation, has introduced the new Nakamura-Tome NTRX-300, a multitasking turning center featuring complete parts machining in one operation, with a built-in load and unload automation system and advanced operator recognition management software. The NTRX-300 features true opposing twin spindles: an 8 in. A2-6 25 HP or […]
  • MSC Apex Diamond Python and Smart Midsurface speeds modeling to validation
    MSC Software announced a new release of MSC Apex, the company’s award-winning next generation Computer Aided Engineering (CAE) platform. The MSC Apex Diamond Python release introduces: · The fourth release of MSC Apex Modeler is a CAE Specific direct modeling and meshing solution that streamlines CAD clean-up, simplification and meshing workflow. New in this release is […]
  • Quality Metrics: FDA’s plan for a key set of measurements to help ensure manufacturers are producing quality medications
    Editor’s Note: This article is written by Ashley Boam and Mary Malarkey from the “FDA Voice” blog. Boam is an FDA’s acting Director of the Office of Policy for Pharmaceutical Quality, the Office of Pharmaceutical Quality and the Center for Drug Evaluation and Research. Malarkey is an FDA’s Director if the Office of Compliance and Biologics Quality […]

Leave a Reply