BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC SENTRY

    MDR report key: 1791190 · Received August 10, 2010

    Report

    Report Number
    6000144-2010-03123
    Event Type
    Injury
    Date Received
    August 10, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S18
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) PRELIMINARY ANALYSIS REVEALED THE DEVICE HAD NO TELEMETRY AND NO PACING OUTPUT. FURTHER ANALYSIS FOUND THE DEVICE LOST TELEMETRY AND FUNCTION DUE TO BATTERY DEPLETION. THERE WAS NO EVIDENCE TO INDICATE THE DEPLETION OF THE BATTERY WAS ANYTHING OTHER THAN NORMAL. THE DEVICE WAS FULLY FUNCTIONAL WHEN POWERED WITH AN EXTERNAL SUPPLY. RESIDUAL VOLTAGE AND IMPEDANCE INDICATED NO ISSUES WITH THE BATTERY. THERE WAS NO SAVE-TO-DISK DATA TO BE RETRIEVED, DUE TO THE DEPLETION, AND NO INFORMATION WAS RECEIVED WITH THE RETURNED DEVICE. THEREFORE, ANALYSIS RESULTS ARE INCONCLUSIVE.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. 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 57 YR Other 6948 IMPLANTABLE TACHY LEAD| 4194 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD