BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 2200556 · Received August 11, 2011

    Report

    Report Number
    2182208-2011-01086
    Event Type
    Injury
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    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): THE DEVICE WAS RETURNED AND ANALYSIS INDICATED THAT CALCULATIONS BASED ON IMPLANT PARAMETERS INDICATE THAT THE DEVICE HAD MET ITS 99.9% EXPECTED LONGEVITY. ANALYSIS OF THE DEVICE MEMORY FOUND THE ERI (ELECTIVE REPLACEMENT INDICATOR) IS THE RESULT OF HIGH INTERNAL BATTERY RESISTANCE. THIS DEVICE IS PART OF THE FIELD ACTION AND HAS TESTED CONSISTENT WITH THE FIELD ACTION. THE LEAD WAS RETURNED AND ANALYSIS REVEALED THE DISTAL CONDUCTOR FRACTURED. IT WAS ALSO NOTED THAT THE DEFIBRILLATION CONDUCTOR WAS DISTORTED, THERE WAS BLOOD/BODY FLUID ON SEVERAL CONDUCTORS (NOT OBSTRUCTED), ALL INSULATORS WERE MELTED, THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THE OUTER INSULATION WAS TORN, THERE WAS AN EXPOSED DEFIBRILLATION COIL WITH WHITE SUBSTANCE AND THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND SLEEVE HEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY VOLTAGE MEASURED LOWER ONE MONTH AGO THAN CURRENT MEASURED VOLTAGE. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD HIGH THRESHOLDS AND WAS REMOVED. THE DEVICE WAS RETURNED AFTER BEING EXPLANTED DUE TO NORMAL BATTERY DEPLETION AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASKU IMPLANTABLE PACING LEAD DTB MEDTRONIC, INC. LEAD/MEDT ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD