MAUDE Adverse Event Report: ABBOTT ENDURITY PACEMAKER, DR, MRI RESTRICTED; implantable pacemaker Pulse-generator

Model Number PM2162

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 10/18/2023

Event Type  Injury  

Event Description

It was reported that the device was explanted and replaced as it is subject to the assurity and endurity pacemaker equipment anomaly advisory issued by abbott on 10 oct 2023 which applies to a subset of devices distributed and implanted outside of the united states.No malfunction was reported, and the patient is in stable condition with no adverse consequences.

Manufacturer Narrative

The device was returned due safety advisory without identified device or use problem.The device was received with normal telemetry and output.Analysis performed did not identify any functional issues.A longevity assessment found the device was operating above the elective replacement indicator (eri) voltage with appropriate remaining longevity.Additional findings indicated through visual inspection of the header attachment area, an anomaly was detected between the pre-molded header and titanium case.A feedthrough leak test was performed, indicating no sign of hermeticity breach.A manufacturing process anomaly consistent with header bonding anomaly may have occurred.The device is included in the assurity and endurity pacemaker equipment anomaly advisory issued by abbott on 10 oct 2023 for a subset of devices distributed and implanted outside of the united states.

• 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): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18911954
• MDR Text Key: 337749838
• Report Number: 2017865-2024-34427
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: PM2162
• Device Lot Number: P000090020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/05/2019
• 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
• Patient Outcome(s): Required Intervention