The FDA took issue with certain practices at Medtronic’s (NYSE:MDT) neuromodulation business, asking the medical device titan to speak for complaints related to the SynchroMed II drug pump.
The federal watchdog agency, which inspected Medtronic’s plant in May, warned that complaint handling for the SynchroMed II pump wasn’t in conformity with guidelines, especially in regard to issues related to motor corrosion that can result in pump failure.
The FDA noted more than 560 complaints for the pumps, including motor stall, worsened pain and vibrating sensations experienced by patients. The agency listened to a series of complaint calls and noted several instances when information provided in the call was not recorded in the complaint.
The agency noted that Medtronic had taken several actions to better manage complaints, but that a follow-up inspection would be necessary to "evaluate implementation and effectiveness."
The FDA also plans to follow up on Medtronic’s complaint investigation protocols, warning that neuromodulation product specialists "did not adequately evaluate complaints" or provide explanations for why investigations did not occur in a string of case. Some of those complaints involved explanted pumps and patient pain and nausea, according to the FDA warning.
Medtronic launched programs to better monitor such complaints and move them up the chain to product investigators, but the FDA wants a follow-up visit to check up on the new practices.
The agency further requested a "prompt meeting" with Medtronic to "discuss the pump motor corrosion failure mode and the scope and timing of corrective actions to address this ongoing problem." The FDA proposed that they meet the morning of Sept. 7, 2012.
"We are working with the FDA to resolve the issues, which primarily relate to our complaint handling and catheter processes," Ellis said. "We do not expect it to have a material impact on our financial results."
Medtronic CFO Gary Ellis noted the warning in yesterday’s conference call discussing the medtech titan’s 1st quarter earnings results.
