BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 1935938 · Received December 3, 2010

    Report

    Report Number
    3004209178-2010-10159
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    January 1, 2010
    Report Date
    November 22, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE NEUROSTIMULATOR (B)(4) REVEALED 'NO ANOMALY FOUND.' THE DEVICE WAS FUNCTIONALLY OK. EXTENSION: (B)(4). THE EXTENSION WAS OK, BUT CUT THROUGH (SUSPECTED EXPLANT DAMAGE). FINAL DEVICE ANALYSIS REVEALED NO SIGNIFICANT ANOMALIES. EXTENSION: (B)(4). A BREACHED DEPRESSION TO THE #1 CONDUCTOR WAS FOUND 5.1 CM FROM THE PROXIMAL END OF THE EXTENSION. CONTINUITY WAS ACCEPTABLE; THERE WERE NO SHORTS BETWEEN CIRCUITS (DRY).

    Description of Event or Problem · 1

    THE PT DIED OF MEDICAL COMPLICATIONS RELATED TO HIS HEALTH. THEY WERE DETERMINED TO BE NATURAL CAUSES. THE CAUSE OF DEATH WAS NOT RELATED TO THE MEDTRONIC DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 7428 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482A51, LOT# NHU138522V| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482A51, LOT# NHU138524V| LEAD: MODEL 3387, LOT# J0340399V