BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3891592 · Received June 24, 2014

    Report

    Report Number
    3004209178-2014-11961
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 22, 2014
    Report Date
    June 2, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37754, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 39286-65, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD. (B)(6).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT A MANUFACTURER REPRESENTATIVE SAW THE PATIENT AND ALL THE IMPEDANCES WERE GOOD. THEY DID A REPROGRAMMING AND EDUCATED THE PATIENT. THE PATIENT SEEMED TO BE BETTER AFTER THE VISIT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS CONFUSING THE COUPLING BARS WITH THE IMPLANTABLE NEUROSTIMULATOR (INS) CHARGE LEVEL. THE PATIENT HAD A SHOCKING OR JOLTING SENSATION. THE PATIENT HAD A BAD FALL A WEEK PRIOR TO THE REPORT ON THURSDAY MORNING. WITH THE FALL, THE PATIENT¿S WHOLE BACK WAS COMPLETELY BRUISED AND THE PATIENT WAS SENT TO THE EMERGENCY ROOM. THEY TOOK ¿ERAYS¿ AND SENT THE PATIENT HOME. THE PATIENT DIDN¿T KNOW UNTIL THE SATURDAY PRIOR TO THE REPORT THAT THEIR INS WAS GETTING LOW. THE PATIENT LAID ON IT FOR 8-10 HOURS AND HAD NO BOXES AND IT ONLY CHARGED A LITTLE BIT AND THE PATIENT DID IT 3 MORE TIMES AND GOT NO COUPLING BOXES. DURING THE REPORT, THE PATIENT WAS ABLE TO GET 4 COUPLING BARS. ON (B)(6), THE PATIENT WAS UP DURING THE NIGHT AND THEY TURNED AND LOST THEIR BALANCE AND HAD A HORRIBLE FALL AND BROKE THEIR DESK AND COULDN¿T GET UP. THE AMBULANCE PICKED THE PATIENT UP BECAUSE THEY COULDN¿T WALK OR GET UP. AFTER THE FALL THE PATIENT HAD ELECTRICAL SHOCKS IN THEIR BACK AND IN THE UPPER BACK. THE PATIENT WAS NOT BEING SHOCKED AT THE TIME OF THE REPORT BUT WAS GETTING SHOCKS FOR A FEW DAYS AFTER THE FALL. THE PATIENT HAD A DOCTOR¿S APPOINTMENT ON 2014 (B)(6). ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS WITH THEIR DEVICE OR THERAPY BUT THEY WERE WORKING WITH THEIR DOCTOR AND A MANUFACTURER REPRESENTATIVE. AN APPOINTMENT DATE OF (B)(6) 2014 WAS NOTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369211 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR