MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC; PULSE-GENERATOR, PACEMAKER, EXTERNAL

Model Number 5392

Device Problems Break (1069); Crack (1135); Degraded (1153); Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/12/2018

Event Type  malfunction  

Event Description

Our facility is experiencing widespread failures of the lead connector of our medtronic 5392 pacemaker fleet.Degradation, cracks, and damage of the lead wire connector causes the lead set to have a loose, intermittent connection or to fall out completely.About 44% of our fleet is affected at this point.To date, we have identified 25 of our 57 pacemakers with damage to the connector.The fear is that eventually, we will lose functionality of the pacemaker while on a patient, or not have a working pacemaker available when it is needed for patient treatment.Medtronic has indicated that the problem is related to the disinfectant used at the hospital.Medtronic has also indicated that the pacemakers should be cleaned with alcohol.Alcohol is not an effective disinfectant.I am currently awaiting some follow up information from medtronic regarding proper cleaning of the pacemakers.Manufacturer response for external pacemaker, medtronic (per site reporter): medtronic has indicated that the pacemakers should be disinfected with alcohol only.I am currently awaiting follow up information regarding other disinfectants that may be used.

• Brand Name: MEDTRONIC
• Type of Device: PULSE-GENERATOR, PACEMAKER, EXTERNAL
• Manufacturer (Section D): MEDTRONIC; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 7281743
• MDR Text Key: 100413340
• Report Number: 7281743
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 5392
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/14/2018
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1