MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ENDURITY PACEMAKER, DR, MRI RESTRICTED; implantable pacemaker Pulse-generator

Model Number PM2162

Device Problems Premature Discharge of Battery (1057); Failure to Interrogate (1332); No Pacing (3268)

Patient Problem Arrhythmia (1721)

Event Date 02/15/2024

Event Type  Injury  

Event Description

It was reported that the patient presented to in clinic follow up with bradycardia.The pacemaker exhibited a lack of pacing output, a failure to be interrogated.Premature battery depletion was suspected.The device was explanted and successfully replaced.The patient was stable.

Manufacturer Narrative

The reported events of no inductive telemetry, premature battery depletion and no output were confirmed.The device was received with no telemetry communication and no output.Visual inspection of the header attachment area detected an anomaly.A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.The device was cut open to enable further testing and the battery was found depleted.Feedthrough leak test was performed, indicating a device hermeticity breach.This is consistent with feedthrough damage as a result of fluid intrusion between the header and case, and subsequent fluid ingress to internal electronics.Hybrid circuitry was tested by connecting to an external power source.Test results indicated elevated current drain, consistent with moisture damage, resulting in the reported event.A manufacturing process anomaly consistent with header bonding anomaly may have occurred.

• Brand Name: ENDURITY PACEMAKER, DR, MRI RESTRICTED
• Type of Device: implantable pacemaker Pulse-generator
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 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
• MDR Report Key: 18793934
• MDR Text Key: 336379406
• Report Number: 2017865-2024-33613
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: VM
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: PM2162
• Device Lot Number: P000100631
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2020
• 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