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

Model Number PM2152

Device Problems Failure to Capture (1081); Failure to Sense (1559); Impedance Problem (2950)

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

Event Date 07/20/2023

Event Type  malfunction  

Event Description

It was reported that during an unrelated device replacement procedure, loss of capture, loss of sensing, and no impedance measurements were noted on the device.The device was explanted and replaced to resolve the event.The patient was in stable condition.

Manufacturer Narrative

The reported events of failure to capture, failure to sense and impedance problem could not be confirmed.The pacer was received in normal working conditions with battery voltage above elective replacement indicator (eri).Electrical and mechanical analysis performed, including sensing, capture and impedance tests under field settings indicated normal device functionality.Performed dhr review to ensure that each manufacturing and inspection operation was performed.The product passed all quality control tests prior to its distribution.Longevity assessment was performed and device was in the normal range of operation with appropriate remaining longevity.

• 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: 17460795
• MDR Text Key: 320515840
• Report Number: 2017865-2023-37579
• 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
• Report Date: 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PM2152
• Device Lot Number: P000172834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/26/2023
• Initial Date FDA Received: 08/04/2023
• Supplement Dates Manufacturer Received: 10/03/2023
• Supplement Dates FDA Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2023
• 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