MAUDE Adverse Event Report: ABBOTT ENDURITY PACEMAKER, DR, MRI RESTRICTED; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM2162

Device Problem Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/18/2023

Event Type  malfunction  

Event Description

During attempted implant, the right atrial (ra) lead could not be inserted into the header of the device.A different device was successfully implanted to resolve the event.The patient was stable and there were no adverse consequences.

Manufacturer Narrative

The reported event of unable to insert the atrial lead in the header/connection problem was not confirmed.The device was received from the field with battery voltage above elective replacement indicator level.Electrical and mechanical analysis performed indicated normal functionality.Further evaluation of the header and connectors found no contamination or foreign material that could contribute to the reported event.During the analysis, the atrial lead was inserted and removed in the device header multiple times without anomaly with normal force.Longevity assessment was performed, and the device was in the normal range of operation with appropriate remaining longevity.

• Brand Name: ENDURITY PACEMAKER, DR, MRI RESTRICTED
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 17117988
• MDR Text Key: 317075445
• Report Number: 2017865-2023-21453
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PM2162
• Device Lot Number: P000165225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/23/2023
• Initial Date FDA Received: 06/13/2023
• Supplement Dates Manufacturer Received: 07/21/2023
• Supplement Dates FDA Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1