MAUDE Adverse Event Report: ABBOTT VERITY ADX SR; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number	5156
Medical Device Problem Codes	Premature Discharge of Battery (1057); Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
During an in clinic follow-up, the device was at elective replacement indicator (eri) voltage level.Premature battery depletion was suspected to be the cause of the event.Additionally, the physician alleged the eri alert was falsely triggered as the remaining voltage was not low enough to be considered eri.The device was explanted and replaced to resolve the event.The patient was in stable condition.
Additional Manufacturer Narrative
The reported event of premature battery depletion was not confirmed.The device was received in backup condition which occurred post-explant caused by exposure to cold temperature.Review of the device image indicated auto-capture was enabled, and the device was in high output mode at times consistent with the false elective replacement alert triggered in the field.When automatic settings are programmed, such as auto-capture, the device output would adjust itself to accommodate the patient¿s needs for pacing and thus affects the estimated longevity of the device.The device code was re-loaded onto the pacer and nominal conditions were programmed without anomaly.Electrical testing was performed under nominal conditions and normal functionality was observed.Additionally, evaluation under various pulse amplitudes indicated normal current level and no indication of premature depletion was revealed.A longevity assessment was performed, and the device was in normal range of operation with appropriate remaining longevity.

• Brand Name: VERITY ADX SR
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 14015176
• Report Number: 2017865-2022-06508
• Device Sequence Number: 4629232
• Product Code: DXY
• UDI-Device Identifier: 05414734006767
• UDI-Public: 05414734006767
• 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: 2011
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2022

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: 05/31/2012
• Device Model Number: 5156
• Device Catalogue Number: 5156
• Device Lot Number: 3254557
• 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: 03/21/2022
• Supplement Date Received by Manufacturer: 05/06/2022
• Initial Report FDA Received Date: 04/05/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2010
• 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