BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3222615 · Received July 12, 2013

    Report

    Report Number
    3004209178-2013-11660
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 21, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37743, SERIAL# (B)(4): PRODUCT TYPE PROGRAMMER; PATIENT PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009: PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009: PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4): PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF STIMULATION 2 DAYS PRIOR TO THE REPORT, AS WELL AS A LOSS OF THERAPEUTIC EFFECT. THE PATIENT WAS HURTING BADLY. THE PATIENT HAD HELP TO TURN THE DEVICE ON AND COULD FEEL THE STIMULATION AGAIN. THE PATIENT STATED THAT SOMETIMES WHEN SHE SLEPT SHE ACCIDENTALLY WOULD TURN HER DEVICE OFF BECAUSE IT CAN HURT HER AT NIGHT. OF NOTE, THE PATIENT DID NOT HAVE A CURRENT PHYSICIAN. ADDITIONAL INFORMATION WAS REQUESTED, IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322784 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 00034 YR