BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 4113113 · Received September 24, 2014

    Report

    Report Number
    3007566237-2014-02678
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Date of Event
    August 19, 2014
    Report Date
    September 2, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37081-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ANALYSIS OF THE EXTENSION FOUND ¿TWO SETSCREW IMPRESSIONS WERE TOO PROXIMAL INDICATING THAT THE EXTENSION WAS NOT COMPLETELY SEATED IN THE INS CONNECTOR PORT. ONE SETSCREW IMPRESSION MAY HAVE INDICATED THAT AT SOME POINT IT DID GET COMPLETELY SEATED IN THE INS CONNECTOR PORT.¿

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ¿AFTER SEVERAL TRIES CONNECTING AND DISCONNECTING¿ THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) AND EXTENSION, THAT ¿NONE OF THE TERMINALS WERE CONNECTED.¿ THERE WAS ¿DAMAGE DETECTED CAPPING THE LEAD.¿ IMPEDANCE TESTING ¿OF THE BATTERY DIRECTLY CONNECTED TO THE ELECTRODE SHOWED THAT ALL OF THE TERMINALS WERE CONNECTED.¿ THE EXTENSION WAS REPLACED AS A RESULT OF THE EVENT AND THE ISSUE WAS RESOLVED. THERE WERE ¿NO CLINICAL CONSEQUENCES¿ OBSERVED WITH THE PATIENT DUE TO THE EVENT AND THE PATIENT¿S ¿NERVE STIMULATION WAS SUCCESSFUL¿ FOLLOWING THE REPLACEMENT OF THE EXTENSION. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593074 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1