BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3782003 · Received April 30, 2014

    Report

    Report Number
    3004209178-2014-08314
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Report Date
    April 9, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD GOOD BILATERAL COVERAGE AND RELIEF IN HER BACK AND BILATERAL LEGS FOR ABOUT THREE MONTHS AND THEN SHE NEEDED ANOTHER SURGERY ON HER BACK. THE PATIENT THEN FOUND OUT SHE WAS PREGNANT AND SHE HAD NOT BEEN USING STIMULATION SINCE. THE PATIENT GAVE BIRTH NINE WEEKS AGO AND COVERAGE SINCE WAS SPOTTY AND HAD CHANGED. A MANUFACTURER REPRESENTATIVE WAS ABLE TO REPROGRAM TO OBTAIN THE PATIENT¿S RIGHT BACK AND LEG BUT THEY WERE UNABLE TO ACHIEVE LEFT COVERAGE. THE PATIENT¿S DOCTOR PERFORMED AN X-RAY THAT DID SHOW THE LEAD RIGHT OF MIDLINE. IT WAS NOTED THE PATIENT HAD LEFT COVERAGE PREVIOUSLY. THE PATIENT HAD LESS THAN 50% THERAPY RELIEF. IT WAS ALSO NOTED IMPEDANCE TESTING WAS PERFORMED BUT RESULTS WERE NOT PROVIDED. ADDITIONAL INFORMATION RECEIVED TWO DAYS LATER REPORTED THE PATIENT TOLD HER DOCTOR SHE HAD TOO MUCH GOING ON WITH JUST GIVING BIRTH AND STILL RECOVERING FROM HER BACK SURGERY TO PURSUE FURTHER REVISION AT THIS TIME THOUGH SHE WOULD LIKE LEFT SIDE COVERAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260146 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 00034 YR