BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3143469 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-08576
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    May 13, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE PATIENT WOULD NOT TURN STIMULATION OFF BECAUSE SHE WOULD GET "SEVERE PAIN" IF SHE DID. IF ADDITIONAL INFORMATION RELATED TO THE EVENT IS RECEIVED, A SUPPLEMENTAL WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT FELL OFF THE COUCH AND LANDED ON HER DEVICE ONE WEEK PRIOR TO THE REPORT. THE REPORTER STATED THAT SINCE THEN, THE STIMULATION WAS IN THE WRONG LOCATION AND WAS NOT ONLY STIMULATING THE PATIENT¿S PRIVATE AREAS, BUT SHE ALSO LOST CONTROL OF HER BLADDER A FEW TIMES. IT WAS REPORTED THAT THE PATIENT HAD CONTACTED HER DOCTOR AND AN APPOINTMENT WAS SCHEDULED FOR THE DAY FOLLOWING THE REPORT. NINE DAYS LATER, IT WAS REPORTED THAT THE PATIENT WAS SEEN ON (B)(6) 2013 AND IMPEDANCES WERE WITHIN THE NORMAL RANGE. IT WAS NOTED THAT STIMULATION WAS REPROGRAMMED AND THE PATIENT WAS GETTING EFFECTIVE THERAPY. IT WAS NOTED THAT NO OTHER DIAGNOSTICS WERE DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243691 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR