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

Model Number	PM1110
Medical Device Problem Codes	Signal Artifact/Noise (1036); Failure to Capture (1081)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented remotely via merlin.Net.Review of the transmission revealed that the pacemaker exhibited noise and failed to capture at max output.The pacemaker was explanted and replaced.The patient was in stable condition.
Additional Manufacturer Narrative
The reported events of failure to capture, and noise were not confirmed.The device was received from the field with battery voltage above elective replacement level.Electrical and mechanical analysis performed indicated normal functionality and capture test under nominal conditions found normal capture results.Output from sensitivity test under field conditions found normal result, and visual inspection of the header and connector detected no contamination or foreign material that could contribute to the reported events.Longevity assessment was performed, and the pacer was in normal range of operation with appropriate remaining longevity.

• Brand Name: ACCENT SR
• Common Device Name: 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 14322256
• Report Number: 2017865-2022-09616
• Device Sequence Number: 5198309
• Product Code: NVZ
• UDI-Device Identifier: 05414734502740
• UDI-Public: 05414734502740
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/31/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2012
• Device Model Number: PM1110
• Device Catalogue Number: PM1110
• Device Lot Number: 3335968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2022
• Supplement Date Received by Manufacturer: 05/20/2022; 05/27/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 05/23/2022; 05/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PKG/STER LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male