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

Model Number PM2210

Device Problems Signal Artifact/Noise (1036); Defective Device (2588)

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

Event Date 12/18/2023

Event Type  Injury  

Event Description

It was reported that the patient presented in the clinic for a follow-up.Upon interrogation, it was noted that noise was observed when touching the header.A header anomaly was suspected.The pacemaker was explanted and replaced.The patient was in stable condition.

Manufacturer Narrative

Reported event of noise was not confirmed.The device was at elective replacement indicator (eri) level upon receipt.Analysis performed in nominal settings, including output verification, sensitivity test, cross talk noise test, and inspection of header and connectors showed normal device characteristics with no anomalies contributing to reported event of noise or pacing problem.Longevity assessment was performed, and device was in the normal range of operation with appropriate remaining longevity.

• Brand Name: ACCENT DR RF PACEMAKER
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• 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: 18504371
• MDR Text Key: 332792575
• Report Number: 2017865-2024-01023
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734503617
• UDI-Public: 05414734503617
• 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: 02/26/2024

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Model Number: PM2210
• Device Lot Number: 3779797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 01/12/2024
• Supplement Dates Manufacturer Received: 02/09/2024
• Supplement Dates FDA Received: 02/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2012
• 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
• Treatment: 2088TC/46 PRUS F/G.; 2088TC/52 PRUS F/G.
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female