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	10/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient presented in clinic on (b)(6) 2022 for a routine follow up, where it was noted upon interrogation that their pacemaker had experienced premature battery depletion.The pacemaker was explanted and replaced on (b)(6) 2022.The patient was stable throughout.
Additional Manufacturer Narrative
The reported event of premature discharge of battery was not confirmed.The device was received from the field with no telemetry, battery at end of service, and corrupted device image consistent with device exposure to electrocautery.After replacing the battery, the device was restored from backup mode successfully, and results from functional testing indicated normal functionality.Further evaluation at various pulse amplitudes measured current levels within normal range and no indication of premature depletion noted.Additionally, results from evaluation of output parameters under nominal conditions were within normal range.Longevity assessment was performed based on field settings and the device exceeded 75% of projected longevity 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
• 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: 16086262
• Report Number: 2017865-2023-00088
• Device Sequence Number: 15113335
• 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: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2023

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: 06/30/2016
• Device Model Number: 5056
• Device Catalogue Number: 5056
• Device Lot Number: 4923769
• 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: 12/26/2022
• Supplement Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/27/2014
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown