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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/28/2023

Event Type  Injury  

Event Description

It was reported that the device was unable to be interrogated via inductive telemetry and and had no magnet response.No intervention has been performed at this time to resolve the event.The patient was in stable condition and will continue to be monitored.

Manufacturer Narrative

The reported events of no pacing output, no inductive telemetry, and no magnet response were not confirmed.The device was received with normal telemetry communication and normal output.Analysis performed did not identify any functional issues.A longevity assessment revealed the device was operating above the elective replacement indicator (eri) voltage level with appropriate remaining longevity.During analysis, a failure event was observed which was unrelated to the reported event.Final analysis revealed an anomaly between the epoxy header and titanium case during a visual inspection of the header attachment area.A feedthrough leak test was performed, indicating a device hermeticity breach.The hybrid circuitry was tested, and the results indicated normal current drain.A manufacturing process anomaly may have occurred, which resulted in the header bonding anomaly.

Event Description

Additional information received indicated loss of pacing was observed on the device.The device was explanted and replaced to resolve the event and the patient was in stable condition.

• 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: 17741816
• MDR Text Key: 323359375
• Report Number: 2017865-2023-43030
• 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: 11/22/2023

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: 09/30/2021
• Device Model Number: PM2152
• Device Lot Number: A000094426
• 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: 11/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2020
• 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