MAUDE Adverse Event Report: ABBOTT ENDURITY PACEMAKER, DR, MRI RESTRICTED; IMPLANTABLE PACEMAKER PULSE-GENERATOR

Model Number PM2162

Device Problems Over-Sensing (1438); Defective Device (2588); No Pacing (3268)

Patient Problem Dizziness (2194)

Event Type  Injury  

Event Description

During an in-clinic follow-up, noise which resulted in oversensing and pacing inhibition was observed on the right ventricular (rv) and right atrial (ra) channels of the device.Additionally, the patient experienced pre-syncopal episodes and dizziness.The suspected cause of the noise was due to a header anomaly.The device was explanted and replaced.The patient was stable.

Manufacturer Narrative

Reported event of sensing noise, no lv output, and header anomaly were not confirmed.The device voltage was above elective replacement indicator (eri) level upon receipt.Analysis of the device image indicated the device was within normal range of operation.Further analysis performed, including output verification, sensitivity test, cross talk noise test, and inspection of header and connectors showed normal device characteristics with no anomaly contributing to reported events of sensing or pacing problem.Assessment of total projected longevity was performed, and the device was found to have appropriate remaining longevity.

• Brand Name: ENDURITY PACEMAKER, DR, MRI RESTRICTED
• 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: 18161014
• MDR Text Key: 328416432
• Report Number: 2017865-2023-72520
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: PM2162
• Device Lot Number: P000019930
• 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: 12/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2015
• 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