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 Codes	Failure to Interrogate (1332); No Pacing (3268)
Health Effect - Clinical Codes	Arrhythmia (1721); Fatigue (1849); Discomfort (2330)
Date of Event	12/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented with bradycardia, fatigue, and malaise.Upon interrogation, it was observed that the pacemaker was at end-of-service, and exhibited a failure to pace and failure to be interrogated through radio frequency (rf) telemetry¿both due to the device being at the end of its expected battery life.The pacemaker was explanted and replaced.There were no patient consequences.
Event or Problem Description
It was reported that the patient presented with bradycardia, fatigue, and malaise.Upon interrogation, it was observed that the pacemaker was at end-of-service, and exhibited a failure to pace and failure to be interrogated through inductive telemetry¿both due to the device being at the end of its expected battery life.The pacemaker was explanted and replaced.There were no patient consequences.
Additional Manufacturer Narrative
Correction: b5 - previously reported "radio frequency (rf) telemetry" should have been "inductive telemetry".
Additional Manufacturer Narrative
The reported events of failure to interrogate and no pacing could not be confirmed.Device image analysis indicated average monthly voltage and current trends were normal.As received the device was at end of life level.New battery was replaced, and electrical, mechanical and pacing functions were analyzed and no anomaly was noted.Output measurement was performed in nominal setting and found to be normal.A longevity calculation was performed and found the battery depletion was normal based on device usage.

• 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: 13054188
• Report Number: 2017865-2021-39620
• Device Sequence Number: 19805300
• Product Code: DXY
• UDI-Device Identifier: 05414734006835
• UDI-Public: 05414734006835
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2021
• 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,Followup
• Report Date (Section B): 04/08/2022

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: 02/28/2009
• Device Model Number: 5356
• Device Catalogue Number: 5356
• Device Lot Number: 0002125432
• 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: 12/03/2021
• Supplement Date Received by Manufacturer: 02/17/2022; 03/18/2022
• Initial Report FDA Received Date: 12/21/2021
• Supplement Report FDA Received Date: 03/18/2022; 04/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2007
• 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: TENDRIL SDX; TENDRIL SDX
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female