BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORESENSOR MRI

    MDR report key: 4161873 · Received October 10, 2014

    Report

    Report Number
    3004209178-2014-19419
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Report Date
    September 22, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 97754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 97740, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 977A260, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 977A260, SERIAL # (B)(6), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A COUPLING PROBLEM AND THE PATIENT WAS HAVING TROUBLE RECHARGING THEIR IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT SAW THE INS RECHARGING SCREEN, BUT ZERO COUPLING BARS WERE BLACK. THIS FIRST STARTED THE WEEK PRIOR TO THE REPORT AND TRIED AGAIN THE NIGH PRIOR BUT WAS STILL NOT GETTING ANY COUPLING BARS. THE PATIENT HAD LOST ABOUT 15 TO 20 POUNDS AND NOTICED THE INS MOVED AND SOMETIMES LOOKED LIKE IT WAS STICKING UP VERSUS LYING FLAT. THIS STARTED ONCE SHE FIRST STARTED TO LOSE WEIGHT. THE PATIENT LAST SUCCESSFULLY CHARGED THE INS IN (B)(6). IT WAS CONFIRMED THAT THE PATIENT HAD ALREADY TRIED ADJUSTING THE ANTENNA DIAL AND MOVING IT AROUND. TROUBLESHOOTING WAS LIMITED DUE TO LACK OF ACCESS TO THE PRODUCT AND/OR PATIENT. AT THE TIME OF THE REPORT THE PATIENT WAS NO AT HOME SO WAS NOT ABLE TO TROUBLESHOOT WITH THE IMPLANTABLE NEUROSTIMULATOR RECHARGER (INSR). INFORMATION HAS BEEN REQUESTED REGARDING IF THE PATIENT STILL HAD CONCERNS WITH THEIR DEVICE OR THERAPY. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639640 RESTORESENSOR MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR