BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 2983454 · Received February 28, 2013

    Report

    Report Number
    3007566237-2013-00630
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    October 31, 2012
    Report Date
    February 14, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37751, PRODUCT TYPE RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    UPDATED WITH ADDITIONAL INFORMATION FOUND ALLEGED NEW DEVICE ISSUES.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS SUSPECTED TO HAVE BEEN IN AN OVERDISCHARGED STATE. COUPLING AND COMMUNICATION ISSUES WERE REPORTED; NO TELEMETRY WAS POSSIBLE WITH CLINICIAN PROGRAMMER OR RECHARGER. THE PATIENT ALLEGED THE DEVICE "HAD NOT WORKED SINCE (B)(6) 2012." IT WAS ALSO STATED THE PATIENT HAD RECHARGED 2 WEEKS PRIOR TO REPORT, BUT STIMULATION STILL HAD NOT WORKED. AN ANTENNA LOCATE FEATURE WAS PERFORMED AND HIGHEST VALUE WAS A 44. IT WAS NOTED THE TOP OF THE INS COULD BE FELT AND GRABBED. A PHYSICIAN MODE RECHARGE (PMR) WAS ATTEMPTED BUT NO TELEMETRY RESPONSE OCCURRED AFTER. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS NOTED THAT THE PATIENT HAD ¿NO COUPLING BASICALLY." ADDITIONAL INFORMATION REPORTED THE BATTERY WAS DRAINING ¿REALLY FAST."

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION. IT WAS REPORTED THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS NOT HOLDING A CHARGE, AND IT HAD TO CHARGE MORE THAN EXPECTED. THE PATIENT'S HEALTH CARE PROVIDER (HCP) HAD DONE A "JUMP START" BUT IT WAS UNCLEAR IF DEVICE WAS BROUGHT OUT OF A DISCHARGED STATE AT THE TIME. ADDITIONAL INFORMATION RECEIVED THE DAY OF REPORT REPORTED THE PATIENT WAS GOING TO HAVE AN X-RAY TO SEE IF THE DEVICE HAD FLIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86375 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR