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

Model Number PM2224

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pocket Erosion (2013)

Event Date 04/08/2024

Event Type  Injury  

Event Description

It was reported, that the patient presented for a follow-up in clinic.With pocket erosion.Blood cultures showed negative result for infection.The pacemaker system was explanted and replaced.The patient was in stable condition.

Manufacturer Narrative

The product was returned and the visual inspection was normal.Interrogation and preliminary test results were acceptable.No anomalies were noted.

• Brand Name: ACCENT MRI DR RF
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• 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: 19178332
• MDR Text Key: 341000045
• Report Number: 2017865-2024-39609
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 05414734504157
• UDI-Public: (01)05414734504157(10)S000088409(17)240430
• 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
• Report Date: 05/02/2024

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: PM2224
• Device Lot Number: S000088409
• 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: 04/14/2024
• Initial Date FDA Received: 04/25/2024
• Supplement Dates Manufacturer Received: 05/01/2024
• Supplement Dates FDA Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2022
• 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