BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3979420 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-13939
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Report Date
    July 11, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3550-29, LOT# N143659, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: ACCESSORY; PRODUCT ID 3708360, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION; PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: RECHARGER; PRODUCT ID 3986A, LOT# N111038, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    THE INS HAS NOT BEEN WORKING AND IT HAS BEEN TURNED OFF ¿FOR A WHILE¿. THE PATIENT HAS NOT BEEN SCHEDULED FOR EXPLANT. IT WAS NOTED THAT THE PATIENT WAS SCHEDULED FOR LITHOTRIPSY FOR KIDNEY STONES. THE INS WAS ONLY 12.5CM FROM WHERE THE LITHOTRIPSY WOULD BE DONE SO THAT WAS ON HOLD UNTIL THE DOCTOR TALKS WITH THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458532 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 00057 YR