MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. VERITY ADX XL; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number	5256
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/13/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
One day following implant, premature battery depletion was reported.The device was explanted and replaced with no adverse consequences to the patient.
Additional Manufacturer Narrative
The device was received with an elective replacement indicator (eri) flag triggered.Analysis of the device image indicated that eri was falsely triggered, consistent with automated settings and exposure to external energy sources.The device analysis detected inconsistencies in voltage and current measurements reported by the device, when compared to measurements using test equipment in the lab.The device was cut open which revealed internal burn marks and damaged integrated circuit, consistent with exposure to external defibrillation.Further measurements performed on the internal circuitry confirmed that battery current and voltage were normal and above eri, with output measurements within the expected range.The cause of the reported premature a battery depletion was unconfirmed.
Event or Problem Description
During follow-up, premature battery depletion was reported.The device was explanted and replaced with no adverse consequences to the patient.

• Brand Name: VERITY ADX XL
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 8472929
• Report Number: 2017865-2019-04803
• Device Sequence Number: 1920523
• Product Code: LWP
• UDI-Device Identifier: 05414734006811
• UDI-Public: 05414734006811
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 06/21/2019

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: 03/31/2015
• Device Model Number: 5256
• Device Lot Number: 4271138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/26/2019
• Supplement Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 04/02/2019
• Supplement Report FDA Received Date: 06/21/2019
• 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: Hospitalization; Required Intervention