BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3240474 · Received July 22, 2013

    Report

    Report Number
    3007566237-2013-02421
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Report Date
    June 25, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37754, SERIAL# (B)(4, PRODUCT TYPE: RECHARGER; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF RECHARGER MODEL 37754 SERIAL # (B)(4) SHOWED A DEFECTIVE TELEMETRY COIL. IT WAS ALSO REPORTED THAT IT WAS CONFIRMED THAT THERE WAS NO COMMUNICATION BETWEEN RECHARGER AND THE IMPLANTABLE NEUROSTIMULATOR (INS). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS BAD COUPLING AND NON-CHARGING OF THE IMPLANTABLE NEUROSTIMULATOR (INS). WHEN THE INS WAS INTERROGATED, THE INS SETTING NEEDED TO BE RESET AS THE SETTING HAD BEEN "WIPED." THE REASON FOR THIS WAS UNKNOWN. THE PATIENT WAS REPROGRAMMED TO ORIGINAL SETTINGS AND A LOANER CHARGER WAS USED. THERE WERE NO PATIENT SYMPTOMS OR INJURIES RELATED TO THIS EVENT. NO FURTHER INFORMATION WAS REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341306 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1