BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 4287870 · Received December 1, 2014

    Report

    Report Number
    3004209178-2014-22336
    Event Type
    Malfunction
    Date Received
    December 1, 2014
    Report Date
    November 7, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 377860, LOT# V010451, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 377860, LOT# V010913, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S ¿WIRES¿ HAD COME LOOSE. IT WASN¿T KNOWN WHEN THIS HAPPENED BUT IT WAS CONFIRMED BY X-RAY, AND THEN SHE WAS GIVEN SHOTS TO HELP. IT WAS NOTED THE PATIENT WANTED TO HAVE HER DEVICE REMOVED BUT DIDN¿T HAVE INSURANCE. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT. UNRELATED INS WENT DEAD; CAN¿T CHARGE EVENT CAPTURED IN PE 700774414.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775805 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1