BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC SENTRY

    MDR report key: 1990353 · Received February 15, 2011

    Report

    Report Number
    6000144-2011-00707
    Event Type
    Injury
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S18
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) ACTUAL LONGEVITY IS < 80% OF 99.9% LONGEVITY LIMIT. THE DEVICE WAS FULLY FUNCTIONAL, WITH NO HIGH CURRENT DRAIN OR EVIDENCE OF BATTERY PROBLEMS. BOTH LOADED AND UNLOADED PACING CURRENT DRAIN LEVELS WERE NORMAL FOR THIS DEVICE OVER THE RANGE OF BATTERY VOLTAGE IT OPERATED UNDER DURING ITS SERVICE TIME. WITHOUT THE HISTORY OF THE PROGRAMMED SETTINGS THROUGHOUT ITS SERVICE LIFE, THERE IS NO WAY TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY HAS DEPLETED WITHIN APPROXIMATELY THREE YEARS. THE PATIENT HAS ATRIAL FIBRILLATION WITH HARDLY ANY ATRIAL PACING, NORMAL VENTRICULAR OUTPUTS AND NO SHOCKS OTHER THAN AT IMPLANT. THE DEVICE REMAINS IN USE. IT WAS FURTHER REPORTED THAT THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY HAS DEPLETED WITHIN APPROXIMATELY THREE YEARS. THE PATIENT HAS ATRIAL FIBRILLATION WITH HARDLY ANY ATRIAL PACING, NORMAL VENTRICULAR OUTPUTS AND NO SHOCKS OTHER THAN AT IMPLANT. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYNC SENTRY IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. 7299 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| O| R 4194 IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD