BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3905486 · Received July 1, 2014

    Report

    Report Number
    3004209178-2014-12335
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Report Date
    June 9, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3037, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 9 7740, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37754, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD AN APPOINTMENT SCHEDULED FOR THURSDAY AND REQUESTED A MANUFACTURER¿S REPRESENTATIVE (REP) TO BE THERE FOR ADAPTIVE STIMULATION PROGRAMMING. IT WAS STATED THAT THE LAST TIME THE PATIENT HAD PROGRAMMING WITH A DIFFERENT REP ¿HE DIDN¿T HELP HER AT ALL¿. IT WAS STATED THAT HE ¿HAD IT UPRIGHT, AND NOT SITTING DOWN, AND EVER SINCE THEN I HAVEN¿T BEEN ABLE TO USE THIS THING RIGHT¿. IT WAS ALSO STATED THAT SHE WOULD SIT HALF WAY UP AND IT JUST ¿STOPPED¿ BECAUSE, IT SAID IT WAS IN UPRIGHT AND NOT SITTING DOWN. IT WAS STATED THAT THE PATIENT COULD NOT STAND BECAUSE, SHE HAS A BAD HIP. IT WAS STATED THAT THE PATIENT¿S INITIAL PROGRAMMING WAS 3 MONTHS AGO (AND LATER STATED 6 MONTHS) AND THEN THE PATIENT STATED SHE DIDN¿T START HAVING PROBLEMS UNTIL 4 MONTHS AFTER IMPLANT. IT WAS STATED THAT THE REP WAS FIRST AWARE OF THE PATIENT¿S REPORTED PROBLEMS AROUND DECEMBER AND ¿TOLD THE PATIENT THAT IF WE COULDN¿T GET IT WORKING BY 6 MONTHS, WE WOULD HAVE TO GO IN AGAIN, AND 6 MONTHS CAME AND WENT AND WE STILL HAVEN¿T DONE ANYTHING¿. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS REGARDING THE DEVICE OR THERAPY BUT THE PATIENT WAS WORKING WITH THE HEALTHCARE PROFESSIONAL (HCP) OR REP. IT WAS STATED THAT THE APPOINTMENT WAS (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385024 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 00054 YR