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

Model Number	5456
Medical Device Problem Codes	Premature Discharge of Battery (1057); Capturing Problem (2891)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during in clinic follow up that the pacemaker exhibited premature battery depletion and high capture threshold.No intervention was reported.The patient was stable and asymptomatic.
Event or Problem Description
New information received notes that the device was explanted.
Additional Manufacturer Narrative
The reported events of premature discharge of battery, and capturing problem were not confirmed.The device was received from the field with battery voltage at elective replacement indicator (eri) level.Electrical and mechanical analysis performed under nominal settings found normal functionality.Further evaluation at various pulse amplitudes measured normal current levels and no indication of premature depletion detected.Further capture analysis found normal capture parameters.Additionally, visual inspection of the header and connector did not find any contamination or foreign material that could contribute to the reported events.Longevity assessment was performed, based on field settings, and the device exceeded projected longevity indicating normal battery depletion.

• Brand Name: VERITY ADX XL VDR
• 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: 17695325
• Report Number: 2017865-2023-42306
• Device Sequence Number: 2634608
• Product Code: DXY
• UDI-Device Identifier: 05414734006910
• UDI-Public: 05414734006910
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/28/2023

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: 07/31/2017
• Device Model Number: 5456
• Device Lot Number: P000022546
• 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: 08/22/2023
• Supplement Date Received by Manufacturer: 10/31/2023; 11/22/2023
• Initial Report FDA Received Date: 09/06/2023
• Supplement Report FDA Received Date: 11/13/2023; 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2016
• 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