The US Food and Drug Administration (FDA) issued two warning letters to Medtronic on Tuesday related to manufacturing nonconformities that resulted in a defibrillator recall earlier this year.
The recall of the Medtronic Cardiac Resynchronization Therapy with Defibrillation (CRT-Ds) and Implantable Cardiovert-Defibrillators (ICDs) models was initiated in January “due to a defect in the manufacturing process,” FDA said, identifying
this as a Class I recall. The defect “causes an out of specification gas mixture inside the device,” according to the February notice.
The site inspections that were then conducted by FDA investigators at two Medtronic manufacturing facilities have now resulted in warning letters, including one issued to the Medtronic Cardiac Rhythm and Heart Failure (CRHF) business in Minnesota and a second to the site associated with the recall—the Medtronic Puerto Rico Operations Company (MPROC). A good manufacturing practices (GMP) violation at this site in Juncos, Puerto Rico was identified as the cause of the recall in both FDA warning letters.
“The warning letters do not impact patients or physicians, and no new action is required by them as all potentially affected devices related to this issue were voluntarily recalled in January and March 2018,” Kathleen Janasz, director of communications at CRHF, told Focus
. “There have been no reports of patient death related to the issues identified in the letters. However, Medtronic has confirmed one device failure, which resulted in the loss of device functionality.”
The Medtronic Juncos Campus (MJC) manufacturing facility approved and implemented processes for design transfer but “qualification was never conducted,” according to the FDA warning letter. The design involves ICDs with Blackwell programmer application software.
Established procedures require MJC to receive CRHF’s approval prior to performing certain activities, such as implementing production process changes. Yet MJC also failed to notify the unit of a process change that was implemented without the required CRHF approval, FDA said.
The response letters FDA received in June and July “appear to adequately address” other inspection observations as first cited in the Form 483s to both manufacturing facilities. These relate to corrective and preventive actions and acceptance activities, among other GMP issues.
Spokesperson Tracy McNulty previously told Focus
manufacturing processes were “updated to prevent the specific manufacturing sequence associated with this issue from occurring.”
Yet some of the actions proposed in the response letters “are still in progress, and a follow-up inspection by FDA will be necessary to verify compliance,” said Blake Bevill, program division director at FDA’s Office of Medical Device and Radiological Health.
The facility in Juncos was among those hit by the recent hurricanes that caused disruption to production on the island.
The company “does not expect the warning letters to result in material negative financial implications to the CRHF division or to Medtronic,” Janasz said. It is “working expeditiously to resolve the issues in the warning letters” and “continues to strive for higher quality throughout the organization by enhancing its systems, processes and accountability.”
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) 7/30/18
Medtronic Puerto Rico Operations Co. 8/23/18