BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3072794 · Received April 23, 2013

    Report

    Report Number
    3007566237-2013-01397
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    April 8, 2013
    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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN. PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SLIT IN A LEAD. IT WAS NOTED THAT "THERE WAS SOME TISSUE OR SOME FLUID IN THAT." IT WAS FURTHER NOTED THAT THEY "SUCKED EVERYTHING OUT." ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE EVENT HAD OCCURRED OVER 4 YEARS AGO. IT WAS REPORTED THAT IMPEDANCES WERE AROUND 9,000 WHICH FROM WHAT THE REPORTER WAS TOLD WAS ¿NO TRUE OPEN CIRCUIT.¿ IT WAS REPORTED THAT ¿SOMEONE MENTIONED WHEN THEY DID THE LEAD REPLACEMENT THERE WAS A SLIT IN THE LEAD.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173625 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention