BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 2931338 · Received January 28, 2013

    Report

    Report Number
    3007566237-2013-00292
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Report Date
    January 9, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE PATIENT HAD NO STIMULATION BECAUSE HE HAD BEEN UNABLE TO CHARGE HIS DEVICE. AT THE TIME OF THIS INFORMATION, IT HAD BEEN 8 WEEKS SINCE THE DEVICE RECEIVED A CHARGE. THE PATIENT WAS ABLE TO HAVE HIS PROGRAMMER AND RECHARGER FOR A TIME BUT EVENTUALLY WAS REQUIRED TO RETURN THE RECHARGER. AN OVERDISCHARGE WAS SUSPECTED. LESS THAN FIVE MONTHS LATER IT WAS REPORTED THAT THE PATIENT WAS IN PAIN AND HIS IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY HAD BEEN DEAD FOR THE LAST SIX MONTHS. IT WAS ALSO REPORTED THE PATIENT HAD NOT CHARGED HIS INS IN AT LEAST SIX MONTHS. MORE THAN TWO WEEKS LATER IT WAS STATED THAT THE PATIENT WAS SCHEDULED FOR AN APPOINTMENT WITH MANUFACTURER'S REPRESENTATIVE ON THAT DAY. ONE DAY LATER IT WAS STATED THAT PATIENT'S GENERATOR WAS COMPLETELY DEPLETED. HIS GENERATOR WAS OVERDISCHARGED. HE WAS UNABLE TO RECHARGE HIS GENERATOR. A PHYSICIAN MODE RECHARGE (PMR) WAS PERFORMED. MORE THAN TWO WEEKS LATER IT WAS STATED THAT THE PATIENT WAS BEING WORKED WITH TO SCHEDULE AN APPOINTMENT. ONE DAY LATER IT WAS REPORTED THAT THE PATIENT WAS IN THE OFFICE TO CLEAR THE POWER ON RESET (POR) AFTER PMR HAD BEEN PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. IT WAS STATED THE PATIENT WAS IN A LOT OF PAIN AND "IN VERY CHRONIC PAIN." THE PATIENT'S BACK AND LEGS WERE HURTING "VERY BADLY." THE STIMULATION WAS REPORTED AS "TURNING OFF" AND IT WAS NOTED THE BATTERY "WENT DEAD A WHILE AGO." IT WAS INDICATED THE ANTENNA LOCATE FEATURE WAS TRIED, BUT WAS UNSUCCESSFUL. IT WAS NOTED A "SLOW CHARGE" NEEDED TO BE DONE. THE PATIENT WAS LOOKING FOR ASSISTANCE IN RECHARGING THEIR DEVICE. TWO DAYS LATER, IT WAS REPORTED THAT THE MANUFACTURER REPRESENTATIVE HAD YET TO MEET WITH THE PATIENT REGARDING THE RECHARGE ISSUES. A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38053 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1