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

Model Number PM2160

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

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

Event Date 04/11/2023

Event Type  Injury  

Manufacturer Narrative

Further information was requested but not received.

Event Description

It was reported that the device was unable to be interrogated via inductive and radiofrequency telemetry during an in clinic follow-up.Additionally, the device did not have a magnet response and was not providing pacing support.The device was explanted and replaced to resolve the event and the patient was in stable condition.

Manufacturer Narrative

The reported events of no pacing, no magnet response, no inductive telemetry, and no radiofrequency telemetry were confirmed.The device was received with no telemetry communication and no output.A visual inspection of the header attachment area detected an anomaly between the pre-cast header and titanium case.The device was cut open to enable further testing and the battery was found depleted.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 results indicated elevated current drain, consistent with moisture damage, resulting in the reported events.A manufacturing process anomaly may have occurred, which resulted in the header bonding anomaly.

• Brand Name: ENDURITY DR
• 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: 16823834
• MDR Text Key: 314097134
• Report Number: 2017865-2023-18587
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734507059
• UDI-Public: 05414734507059
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Model Number: PM2160
• Device Catalogue Number: PM2160
• Device Lot Number: P000002336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2015
• 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