MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ACCENT SR; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM1110

Device Problem No Pacing (3268)

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

Event Date 01/26/2022

Event Type  malfunction  

Event Description

It was reported that the patient presented to the hospital for a scheduled implant procedure.During the procedure, the pacemaker was found to have no pacing output.The pacemaker was then removed and replaced.The patient was in stable condition throughout.

Manufacturer Narrative

The reported event of no pacing could not be confirmed.Final analysis found that as received, the device battery voltage was above elective replacement indicator (eri) level.The device was then programed to nominal settings for the remainder of the analysis.The results of all electrical test performed, including mechanical stress testing, output test and battery assessment indicate normal device characteristics.Longevity assessment was performed, and device was in the normal range of operation with appropriate remaining longevity.

• Brand Name: ACCENT SR
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 15821858
• MDR Text Key: 304218707
• Report Number: 2017865-2022-45736
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734502740
• UDI-Public: 05414734502740
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2022

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 Expiration Date: 09/30/2022
• Device Model Number: PM1110
• Device Catalogue Number: PM1110
• Device Lot Number: S000081552
• 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: 10/30/2022
• Initial Date FDA Received: 11/17/2022
• Supplement Dates Manufacturer Received: 12/03/2022
• Supplement Dates FDA Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2021
• 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