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

Model Number PM2110

Device Problems Failure to Interrogate (1332); No Pacing (3268)

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

Event Date 12/20/2022

Event Type  malfunction  

Event Description

Related manufacturer reference number: 2017865-2023-00706.Related manufacturer reference number: 2017865-2023-00707.It was reported that during a device upgrade procedure, the device stopped pacing and could not be interrogated.Inspection of the atrial and ventricular leads showed significant insulation breach between the suture sleeves and proximal connector pins.The device was explanted and replaced.The atrial and ventricular leads were capped and replaced.There were no adverse health consequences, the patient was stable.

Manufacturer Narrative

The reported event of failure to interrogate and no pacing could not be confirmed.Visual examination noted burn marks on the device from exposure to electrosurgical cautery.User's manual indicated that electrosurgical cautery could inhibit the pulse generator operation.As received, the device battery voltage was above elective replacement indicator 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 and battery assessment indicate normal device characteristics.

• Brand Name: ACCENT DR
• 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: 16124622
• MDR Text Key: 307174884
• Report Number: 2017865-2023-00705
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734503600
• UDI-Public: 05414734503600
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/26/2023

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 Expiration Date: 10/31/2014
• Device Model Number: PM2110
• Device Catalogue Number: PM2110
• Device Lot Number: 4050042
• 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: 12/20/2022
• Initial Date FDA Received: 01/09/2023
• Supplement Dates Manufacturer Received: 02/23/2023
• Supplement Dates FDA Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2013
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Weight: 82 KG