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

Model Number	5056
Medical Device Problem Codes	Premature Discharge of Battery (1057); Failure to Interrogate (1332)
Health Effect - Clinical Code	Dizziness (2194)
Date of Event	08/02/2019
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.The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
It was reported that the patient presented in clinic feeling faint.Upon review, the pacemaker was unable to be interrogated and it was discovered that the device exhibited premature battery depletion.The device was explanted and replaced and the patient was stable post-procedure.
Additional Manufacturer Narrative
The reported events of premature depletion and failure to interrogate were confirmed.The device was cut open and no high current drain was found.No anomalies or high current drain were found during functional testing.The battery was also sent for analysis and no anomalies were noted.The device projected longevity is 11.86 years, based on normal settings, and device was implanted for 1.81 years, which is considered premature 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: 9084481
• Report Number: 2017865-2019-13606
• Device Sequence Number: 19688649
• 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: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2020

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: 05/31/2018
• Device Model Number: 5056
• Device Catalogue Number: 5056
• Device Lot Number: S000026890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 09/18/2019
• Supplement Report FDA Received Date: 02/13/2020
• 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
• Patient Weight: 57