BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NEUROSTIMULATOR

    MDR report key: 3881371 · Received June 18, 2014

    Report

    Report Number
    3007566237-2014-01700
    Event Type
    Injury
    Date Received
    June 18, 2014
    Report Date
    June 2, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    PRODUCT ID: NEU_UNKNOWN_EXT, SERIAL# UNKNOWN, PRODUCT TYPE: EXTENSION. PRODUCT ID: NEU _UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS GOING TO HAVE A DEEP BRAIN STIMULATOR (DBS) POCKET REVISION. IT WAS NOTED THE BATTERY WAS IN THE RIGHT CHEST AND THE PATIENT HAD ANOTHER MANUFACTURER¿S DEVICE IN THE LEFT CHEST.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE POCKET REVISION WAS EROSION IN THE RIGHT CHEST. IT WAS NOTED IMPEDANCES WERE NORMAL BEFORE REVISION AND ALL WERE NORMAL AFTER THE REVISION. DURING THE REVISION, THE EXTENSIONS WERE DISCONNECTED FROM THE BATTERY AND THE BATTERY WAS MOVED TO THE RIGHT AXILLARY AREA. IT WAS STATED THE EXTENSIONS WERE RECONNECTED TO THE BATTERY AND A GRAM STAIN WAS OBTAINED AND THE CULTURES WERE SENT. IT WAS NOTED THE PATIENT RECEIVED EFFECTIVE THERAPY. IT WAS FURTHER REPORTED THE RESULTS OF THE CULTURES WERE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357781 UNKNOWN NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Required Intervention