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

Model Number	5156
Medical Device Problem Code	Pacemaker Found in Back-Up Mode (1440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient presented in clinic for routine follow-up.Upon interrogation, it was found that patient's pacemaker was in backup mode.It was also noted that device was at low battery status.No intervention was done.The patient status was unknown.
Event or Problem Description
New information received notes that the device was explanted and replaced.
Additional Manufacturer Narrative
The reported event of device in backup mode was confirmed.The device was received from the field with no output and no telemetry.Review of the device image indicates the device triggered backup operation consistent with low voltage fluctuation.Electrical tests performed, after replacing the battery, and re-loading the device code, indicates normal functionality.Further evaluation of the output parameters found no anomaly.Longevity assessment was performed, and the pacer exceeded projected longevity indicating normal battery depletion.No anomalies were found.

• Brand Name: VERITY ADX 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 17952959
• Report Number: 2017865-2023-49959
• Device Sequence Number: 20788548
• Product Code: DXY
• UDI-Device Identifier: 05414734006767
• UDI-Public: 05414734006767
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/19/2023

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: 01/31/2009
• Device Model Number: 5156
• Device Lot Number: 0002124105
• 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: 09/29/2023
• Supplement Date Received by Manufacturer: 10/31/2023; 12/13/2023
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 11/16/2023; 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2007
• 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: RIGHT VENTRICULAR LEAD.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male