BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN STIMULATOR

    MDR report key: 2913895 · Received January 14, 2013

    Report

    Report Number
    3007566237-2013-00148
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Report Date
    December 21, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICES: PRODUCT ID: 3777-45, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD; PRODUCT ID: 3777-45, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD; PRODUCT ID: 37752, SERIAL#: (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID: 37712, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS OVER-DISCHARGED. INFORMATION SHOWED PATIENT HAD ONE INS BUT REPRESENTATIVE BELIEVED THE PATIENT HAD TWO. BOTH DEVICES WERE OVER-DISCHARGED ACCORDING TO REPRESENTATIVE. THE PATIENT HAD LAST FELT STIMULATION TWO MONTHS PRIOR. IT WAS NOTED THE PATIENT HAD A PREVIOUS OVER-DISCHARGE EVENT ONE YEAR AGO. IT WAS NOTED THIS WAS DUE TO DIFFICULTY RECHARGING, THE PATIENT COULD ONLY GET FOUR BARS FOR COUPLING AND IT WOULD TAKE FOUR HOURS TO CHARGE. IT WAS NOTED THIS WAS DUE TO THE INS BEING DEEPER IN THE POCKET. IT WAS NOTED THE PATIENT HAD LOST A LOT OF WEIGHT RECENTLY, APPROXIMATELY 40 POUNDS. THE INS WAS NOW CLOSER TO THE SKIN SO RECHARGING SHOULD NOT BE AN ISSUE. IT WAS NOTED THEY WERE IN THE PROCESS OF DOING A PHYSICIAN MODE RECHARGE (PMR) BUT HAD BEEN UNSUCCESSFUL. IT WAS NOTED FOUR PMR'S HAD BEEN ATTEMPTED IN FOUR HOURS. FOLLOW UP REPORTED THE CAUSE OF THE OVER-DISCHARGE WAS POSSIBLE LACK OF COMPLIANCE WITH CHARGING AND OR DIFFICULTY CHARGING. IT WAS NOTED THERE WAS NOT A SUCCESSFUL PMR. THE PATIENT HAD BEEN EXPERIENCING AN INCREASE IN PAIN. THERE WAS NO FURTHER TROUBLESHOOTING DONE AND THE PATIENT WAS STILL NOT RECEIVING THERAPY. FURTHER FOLLOW UP REPORTED THE REPRESENTATIVE MET WITH PATIENT AND ATTEMPTED PMR ON BOTH BATTERIES WITH THREE CYCLES EACH. THE REPRESENTATIVE WAS UNABLE TO "WAKE UP" THE BATTERY. PATIENT HAD PLANNED TO MEET WITH THEIR PHYSICIAN TO DISCUSS OPTIONS. REFER TO MANUFACTURER REPORT # 3004209178-2013-00531 FOR REPORT ON INS OVER-DISCHARGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21136 UNKNOWN STIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1