FDA warns Medtronic on CRM plants in Minnesota, Puerto Rico

The FDA this week released warning letters it sent to Medtronic (NYSE:MDT) over issues with cardiac rhythm management plants in Minnesota and Puerto Rico. 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 manufac...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Medtronic Warning Letter Source Type: news