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

Model Number PM2224

Device Problems Pacemaker Found in Back-Up Mode (1440); Inappropriate or Unexpected Reset (2959)

Patient Problems Dizziness (2194); Discomfort (2330)

Event Date 02/13/2023

Event Type  Injury  

Event Description

It was reported that the patient presented for follow-up with a complaint of dizziness and malaise.Further evaluation found that the implantable cardioverter-defibrillator was in backup operation related to a hardware reset.High-voltage therapy was unavailable at the time.The device could not be restored and was pending explant.The patient was in unstable condition.

Manufacturer Narrative

Further information was requested, but not received.

Manufacturer Narrative

Correction: h6 - medical device problem code.

Event Description

New information received notes that the device was explanted and replaced.The patient was stable.

Manufacturer Narrative

Correction: d1, d4, and h4.

Manufacturer Narrative

The reported event of ¿pacemaker found in back-up mode¿ was confirmed.Interrogation of the device revealed the device was in backup mode due to low battery voltage when received.The device battery reached end of life due to high current caused by an anomalous integrated circuit on the radio frequency module.A longevity calculation was performed and found the battery depletion was premature based on the device usage.

Manufacturer Narrative

A device history record (dhr) review was performed and all required manufacturing processes and inspection steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.

• Brand Name: ACCENT MRI DR RF
• 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: 16492731
• MDR Text Key: 310784438
• Report Number: 2017865-2023-11980
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P140033
• 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,Followup,Followup,Followup
• Report Date: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: PM2224
• Device Lot Number: S000084326
• 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: 02/15/2023
• Initial Date FDA Received: 03/06/2023
• Supplement Dates Manufacturer Received: 03/13/2023; 03/03/2023; 05/05/2023; 09/05/2023
• Supplement Dates FDA Received: 03/14/2023; 03/23/2023; 05/11/2023; 09/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2021
• 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
• Patient Outcome(s): Required Intervention