MAUDE Adverse Event Report: ABBOTT ENDURITY¿ CORE SR, MRI (US); IMPLANTABLE PACEMAKER PULSE-GENERATOR

Model Number PM1140

Device Problems Over-Sensing (1438); Failure to Disconnect (2541); Connection Problem (2900)

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

Event Date 07/27/2023

Event Type  Injury  

Event Description

During an in-clinic follow-up, high pacing impedance and noise were observed on the right ventricular (rv) channel.Diagnostic imaging was performed and a connection issue between the device and the rv lead were observed.A revision procedure was performed.While trying to disconnect the device and the lead, there were difficulties loosening the set screw.The device and the lead were disconnected the lead was tested and found to have acceptable measurements.The device was explanted and a new device was connected to the rv lead.The high pacing impedance and noise were detected on the new device.Damage to the rv lead ring was suspected.The new device was programmed and resolved the event.The patient was stable and will continue to be monitored.

Manufacturer Narrative

Reported event of inadequate insertion and sensing noise were not confirmed.Reported event of failure to disconnect was confirmed.The device voltage was above elective replacement indicator (eri) level upon receipt.Analysis revealed the ventricular set screw was stripped due to improper insertion of the torque driver into hex cavity and was the cause of the reported event.The set screw anomaly was consistent with having occurred during the procedure.Further analysis found no anomaly contributing to reported event of sensing problem.Assessment of total projected longevity was performed, and the device was found to have appropriate remaining longevity.

• Brand Name: ENDURITY¿ CORE SR, MRI (US)
• 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: 17512899
• MDR Text Key: 320912734
• Report Number: 2017865-2023-38033
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: PM1140
• Device Lot Number: P000041129
• 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: 09/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2017
• 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