BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3548089 · Received January 2, 2014

    Report

    Report Number
    3004209178-2014-00062
    Event Type
    Malfunction
    Date Received
    January 2, 2014
    Report Date
    December 11, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: RECHARGER. PRODUCT ID: 3777-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 377775, LOT# V013204, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS STIMULATION IN THE WRONG LOCATION. IT WAS NOTED THAT THE PATIENT¿S LEADS MOVED AND IT RESULTED IN THE PATIENT GETTING STIMULATION DOWN THEIR LEG. IT WAS NOTED THAT THE DECISION WAS TO LET THE DEVICE RUN OUT OF POWER AND NOT CHARGE IT ANY LONGER. IT WAS NOTED THAT THE REPORTER ¿THREW OUT THE TIME FRAME OF A COUPLE OF YEARS AGO¿ BUT DID NOT KNOW FOR CERTAIN. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00091 YR