The federal safety watchdog said inspections in April and May at both plants turned up problems related to the recall of CRM devices over high-voltage arcing, which led to the recall of some 800 implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators.
In January the Fridley, Minn.-based company informed physicians of the recall of 48 of the devices that were “sent through a manufacturing sequence that introduced the potential for internal arcing during high-voltage charging, leading to the immediate and permanent loss of device functionality.”
The issue led to a single instance in which an implanted device failed and external defibrillation was required to rescue the patient. The affected CRT-Ds are from Fridley, Minn.-based Medtronic’s Amplia, Claria, Compia and Viva lines. The ICDs involved in the recalls are from the Evera and Visia lines.
In March Medtronic added another 752 CRT-Ds and ICDs to the recall, saying they “may have undergone a specific sequence of manufacturing processes that could lead to an out-of-specification internal gas environment.”
“This may introduce a risk for internal arcing during high-voltage charging, resulting in immediate and permanent loss of device functionality, including pacing and high-voltage therapy. This specific manufacturing sequence is no longer performed. There have been no patient injuries or deaths reported in this advisory population,” the company said in a doctor’s letter.
The FDA launched inspections at the facility in Mounds View, Minn., from April 23 to May 14, and issued a Form 483 that last day with observed violations including failure to establish adequate procedures for design transfer and changes to the production process, according to the July 30 warning letter concerning that plant.
“Specifically, design transfer was approved for Blackwell implantable cardiac defibrillators (ICDs) prior to qualification of [redacted] processes. Even though a qualification was never conducted, [redacted] process [redacted] was implemented at the Medtronic Juncos Campus (MJC) manufacturing facility. The [redacted] process [redacted] in ICDs that failed due to high voltage arcing. This led to your firm’s recall Z-0582/9-2018,” according to the letter, referring to the product line moniker from before they were officially named.
The letter also cited the Mounds View plant for failing to review and approve a process change implemented at the plant in Juncos, Puerto Rico, and noted that the agency plans to conduct follow-up inspections in Minnesota to verify changes promised to the corrective and preventive action plan.
In Juncos, inspections from April 23 to May 14 led to a Form 483 the following day, citing Medtronic’s failure to “validate a process whose results cannot be fully verified by subsequent inspection and test according to established procedures.”
“Specifically, [redacted] processes [redacted] were not validated on Blackwell implantable cardiac defibrillators (ICDs). These [redacted] processes [redacted] in ICDs that failed due to high voltage arcing. This led to your firm’s recall Z-0582/9-2018,” according to the August 23 letter, which also flagged a failure to properly document the device history record. As in Minnesota, the FDA said follow-up inspection is on tap to verify changes to the CAPA, acceptance procedures, statistical techniques and inspection measuring & test equipment in Juncos.
The FDA noted that Medtronic’s responses, in June and July, to the Form 483 observations at both plants “appear to be adequate” and re-iterated that follow-up inspections are in store.
A Medtronic spokeswoman told MassDevice.com via email today that “all potentially affected defibrillators were recalled in January and March 2018.”
“We are working with FDA to resolve the outstanding issues as quickly and thoroughly as possible,” she wrote.