BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3922206 · Received July 9, 2014

    Report

    Report Number
    3004209178-2014-12700
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Report Date
    June 17, 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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8590-9, LOT# N295983, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8590-9, LOT# N296982, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BEEN ¿AT THEIR OFFICE¿ ON THE DAY PRIOR TO THIS REPORT AND WHEN SHE TURNED ON HER STIMULATION, IT SHOCKED HER. IT WAS STATED THAT THE PATIENT HAD FALLEN IN (B)(6) OF 2012, AFTER WHICH ¿IT¿ STOPPED WORKING. IT WAS STATED THAT AFTER THE FALL THE PATIENT HAD TRIED TO TURN HER STIMULATION ON AND IT SHOCKED HER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400053 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR