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

Model Number	5256
Medical Device Problem Codes	Premature Discharge of Battery (1057); Failure to Interrogate (1332); Pacing Inadequately (1442)
Health Effect - Clinical Code	Syncope (1610)
Date of Event	02/18/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
During a follow-up in clinic, the device could not be interrogated and was pacing inadequately.Premature battery depletion was suspected.The patient was admitted to the hospital for device replacement, and during the hospital stay the patient had fallen due to an asystole episode.A temporary pacer was used until the device could be replaced.The device was explanted and replaced, and the patient was stable following the procedure.
Additional Manufacturer Narrative
As received, the device was in backup mode and the battery at end of life (eol) level.Analysis of the device image indicated that backup mode was triggered post explant and resulted from low battery condition.The device image also indicated that autocapture was enabled and the device was operating in high output mode (hom) at times, which is consistent with the false elective replacement indicator (eri) flag and remaining longevity after the follow up visit.Assessment of devices longevity indicated that the total longevity was met but eri to eol interval was less than expected.Further analysis was performed by cutting open the device to make direct measurements on the internal circuitry, which revealed high current drain from the hybrid circuitry.Additional hybrid testing concluded that c6 capacitor was the cause of high current drain, which resulted in shortened eri to eol interval.The reported event of premature battery depletion was confirmed.

• 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: 8396259
• Report Number: 2017865-2019-03383
• Device Sequence Number: 3219291
• Product Code: LWP
• UDI-Device Identifier: 05414734006811
• UDI-Public: 05414734006811
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• 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): 06/27/2019

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: 03/31/2007
• Device Model Number: 5256
• Device Lot Number: 3050430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/18/2019
• Supplement Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 06/27/2019
• 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