MAUDE Adverse Event Report: ABBOTT ENDURITY¿ CORE DR, JPD; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number PM2152

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

Patient Problems Arrhythmia (1721); Dizziness (2194)

Event Date 09/05/2023

Event Type  Injury  

Event Description

The patient presented in the emergency room after experiencing episodes of dizziness and bradycardia.Upon investigation, the device was no longer providing pacing and was unable to be interrogated via inductive telemetry.The device was explanted and replaced to resolve the event.The patient was in stable condition.

Event Description

Additional information received indicated the patient entered asystole which required cardiopulmonary resuscitation.The patient was given a temporary pacemaker to stabilize them before the implanted device was explanted and replaced.The patient was in stable condition.

Manufacturer Narrative

The reported events of no output and no inductive telemetry were confirmed.The device was received with no output and no telemetry communication.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 was found at normal level.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, and the 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¿ CORE DR, 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: 17737323
• MDR Text Key: 323290173
• Report Number: 2017865-2023-42957
• 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,Followup,Followup
• Report Date: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: PM2152
• Device Lot Number: P000100097
• 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: 11/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2020
• 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