MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 5356 VERITY DR, AB 20 55 184; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number	5356
Medical Device Problem Code	Failure to Interrogate (1332)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the asymptomatic patient presented for a follow up in clinic with a pulse generator that exhibited failure to interrogate.The device was explanted and replaced.The patient was in stable condition before, during, and after the procedure.
Additional Manufacturer Narrative
The reported event of unable to interrogate was not confirmed.The device was received with battery voltage in normal range of operation.Analysis of the device image did not show any anomalies.Analysis performed indicated normal device characteristics, and the device was able to be interrogated through inductive telemetry.Longevity assessment was performed, and device was normal, and met projected longevity.

• Brand Name: 5356 VERITY DR, AB 20 55 184
• 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: 14149213
• Report Number: 2017865-2022-08338
• Device Sequence Number: 2996844
• Product Code: DXY
• UDI-Device Identifier: 05414734006835
• UDI-Public: 05414734006835
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• 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: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2022

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: 06/30/2008
• Device Model Number: 5356
• Device Catalogue Number: 5356
• Device Lot Number: 0002125619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2022
• Supplement Date Received by Manufacturer: 06/14/2022
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2006
• 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: RA LEAD; RV LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 81 KG