BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3446251 · Received November 4, 2013

    Report

    Report Number
    3004209178-2013-20117
    Event Type
    Malfunction
    Date Received
    November 4, 2013
    Report Date
    October 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3986A, LOT# N212309, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD; PRODUCT ID 3986A, LOT# N226630, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD; PRODUCT ID 37083-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION; PRODUCT ID 37082-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION; PRODUCT ID 3550-29, LOT# N130538, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ACCESSORY; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 3986A, LOT# N226630, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD; PRODUCT ID 3986A, LOT# N212309, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENTS ¿NUMBER 2 LEAD WAS NOT WORKING PROPERLY¿ AND WAS ¿DISCONNECTED¿. WHEN THE PATIENT CHECKING HIS IMPLANTABLE NEUROSTIMULATOR (INS) HE INCREASED STIMULATION ON PROGRAM 2 AND THE ONLY TIME HE FEELS STIMULATION WAS IF HE PUT HIS CHIN INTO HIS CHEST. LOSS OF THERAPEUTIC EFFECT WAS REPORTED. CALLER STATED THAT HE WAS IN ¿SO MUCH PAIN¿ AND WAS SORE AND WAS NOT SLEEPING AT NIGHT. THE LAST 2 NIGHTS HE HAD BEEN SLEEPING A LOT. SYMPTOMS OCCURRED ABOUT A WEEK AGO. PATIENT STATED HE DID NOT HAVE ANY FALLS OR TRAUMAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567210 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 00054 YR