BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3459818 · Received November 12, 2013

    Report

    Report Number
    3004209178-2013-20521
    Event Type
    Malfunction
    Date Received
    November 12, 2013
    Report Date
    November 4, 2013
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD BEEN DISSATISFIED WITH HIS DEVICE SINCE THE TIME OF IMPLANT. THE PATIENT REPORTEDLY HAD ¿A LOT OF PROBLEMS WITH IT.¿ IT WAS STATED THAT THE PATIENT HAD MET WITH A MANUFACTURER¿S REPRESENTATIVE 3-4 TIMES TO HAVE PROGRAMMING ADJUSTED BUT ¿IT JUST DIDN¿T STAY LIKE THAT¿, AND THAT HE THOUGHT IT WOULD FEEL GOOD BUT THEN ¿A COUPLE DAYS LATER IT WAS NOT WORKING THE SAME.¿ IT WAS ALLEGED THAT WHEN THE PATIENT LEANED BACK ¿IT ZAPPED HIM.¿ IT WAS NOTED THAT IT HAD ALWAYS BEEN THAT WAY, STATING WHEN HE STRETCHED BACK ¿WHEN HE GOT IT ON IT INCREASED.¿ THE PATIENT REPORTEDLY HAD BEEN TOLD ¿IT WAS THE TISSUE ALL AROUND IT AND ¿ALL THIS CRAP¿ BUT IT HADN¿T GOTTEN ANY BETTER.¿ IT WAS STATED THAT THE PATIENT HAD NOT HAD ANY SYMPTOM RELIEF AND ¿STILL FELT THE PAIN DOWN INSIDE.¿ IT WAS NOTED THAT IT WAS ¿FINE,¿ BUT THE PATIENT ¿FOUND NOTHING TO WORK AT ALL,¿ STATING ¿IF PERMANENT NERVE DAMAGE WAS WHAT I HAD, OBVIOUSLY THIS THING AIN¿T GONNA WORK.¿ IT WAS NOTED THAT THE PATIENT¿S TRIAL WORKED BETTER THAN THE PERMANENT IMPLANT AND WHEN THEY SURGICALLY ¿PUT IT IN, IT HAD NOT WORKED LIKE THE TEMPORARY ONE.¿ THE PATIENT REPORTEDLY STATED ¿IT WAS NOTHING LIKE THE DVD WITH THE GUY STATING IT WAS ALL TERRIFIC¿ AND THAT THEY ¿HAD NOTHING BUT CRAP LUCK WITH IT.¿ THE PATIENT REPORTEDLY WAS ¿NOT HAPPY WITH THIS SYSTEM AT ALL,¿ ¿DISAPPOINTED WITH IT COMPLETELY,¿ AND WOULD ¿GET IT OUT¿ IF IT ¿DID NOT TAKE AN OPERATION.¿ IT WAS NOTED THAT THE PATIENT HAD DISCUSSED IT WAS NOT WORKING WITH HIS HEALTHCARE PROVIDER AND REFUSED AN ADDITIONAL LEAD OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585744 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 00050 YR