BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 2920820 · Received January 17, 2013

    Report

    Report Number
    3007566237-2013-00227
    Event Type
    Injury
    Date Received
    January 17, 2013
    Report Date
    December 21, 2012
    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

    PRODUCT ID NEU_SILICONE ANCHOR, IMPLANTED: 2008-(B)(6), EXPLANTED: 2012-(B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID 388733, SERIAL# (B)(4), IMPLANTED: 2008-(B)(6), EXPLANTED: 2012-(B)(6), PRODUCT TYPE LEAD. (B)(4): FINAL ANALYSIS OF THE LEAD REVEALED THAT THE CONDUCTORS WERE BROKEN AT THE SILICONE ANCHOR SITE. ALL CIRCUITS WERE OPEN AND THERE WERE NO SHORTS BETWEEN CIRCUITS. ALL FOUR CONDUCTORS WERE BROKEN 18.7 CM FROM THE DISTAL END OF THE LEAD. THERE WAS SURFACE DISCOLORATION ON THE #1 ELECTRODE CONNECTOR. FINAL ANALYSIS OF THE ANCHOR REVEALED THAT THE ANCHOR HAD BEEN CUT TO LENGTH AND THERE WAS NO SIGNIFICANT ANOMALY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERAPEUTIC RESPONSE WAS REDUCED AND THERE WERE HIGH IMPEDANCES AND A SUSPECTED LEAD FRACTURE. IT WAS REPORTED THAT THERE WAS NO FEELING OF STIMULATION AND THE IMPEDANCE OF ALL COMBINATIONS SHOWED OVER 4000 OHMS. A LEAD REPLACEMENT WAS SCHEDULED. IT WAS FURTHER REPORTED THAT DURING "TRIAL STIMULATION" THE PATIENT DIDN'T FEEL STIMULATION. IT WAS UNCLEAR WHAT "TRIAL STIMULATION" REFERRED TO. ON (B)(6)-2012 THE LEAD WAS REMOVED, A NEW LEAD WAS IMPLANTED, AND THE PATIENT FELT APPROPRIATE THERAPY. IT WAS REPORTED THAT THE PATIENT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26533 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention