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

Model Number	5056
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
It was reported that the patient presented for in-clinic follow up.Upon interrogation of the pulse generator premature battery depletion was observed.The patient was scheduled for explant and the device was successfully replaced.The patient was in stable condition.
Additional Manufacturer Narrative
Field complaint of premature discharge of battery was not confirmed.The device was received with normal device characteristics.Analysis of device image indicated that the device operated at high field settings during implant period.Further analysis performed did not find any anomalies, with battery voltage above eri level.Longevity assessment was performed, and the implant duration exceeds the total projected longevity based on field settings indicating normal battery depletion.

• Brand Name: VERITY ADX XL
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 11923558
• Report Number: 2017865-2021-20198
• Device Sequence Number: 4345099
• Product Code: DXY
• UDI-Device Identifier: 05414734006712
• UDI-Public: 05414734006712
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2021

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: 11/30/2016
• Device Model Number: 5056
• Device Catalogue Number: 5056
• Device Lot Number: P000008330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/15/2021
• Supplement Date Received by Manufacturer: 05/15/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention