MAUDE Adverse Event Report: ABBOTT ENDURITY¿ CORE SR, JPD; Pulse generator, permanent, implantable

Model Number PM1152

Device Problems Failure to Interrogate (1332); No Pacing (3268)

Patient Problems Arrhythmia (1721); Fatigue (1849)

Event Date 01/03/2024

Event Type  Injury  

Event Description

It was reported that the patient presented in the hospital with complaints of fatigue and a slow heartrate.Upon investigation, the device was not providing pacing support, unable to be interrogated via inductive telemetry, and had no magnet response.The device was explanted and replaced to resolve the event and the patient was in stable condition.

Manufacturer Narrative

The reported events of no output, no inductive telemetry and no magnet response were confirmed.The device was received with no output and no telemetry communication.A visual inspection of the header attachment area detected an anomaly between the pre-casted header and titanium case.The device was cut open to enable further testing and the battery voltage was found at normal level.The 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.The hybrid circuitry was tested, and the current drain was normal.A manufacturing process anomaly may have occurred, which resulted in the header bonding anomaly.

• Brand Name: ENDURITY¿ CORE SR, JPD
• Type of Device: Pulse generator, permanent, implantable
• 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: 18530710
• MDR Text Key: 333069726
• Report Number: 2017865-2024-01390
• Device Sequence Number: 1
• Product Code: NVZ
• 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
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• 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: PM1152
• Device Lot Number: P000100788
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2020
• 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; Other