BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3821999 · Received May 20, 2014

    Report

    Report Number
    3004209178-2014-09315
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Report Date
    April 28, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS HOT WHILE IN USE OR WHILE RECHARGING. IT WAS STATED THAT THERE WERE NO TEMPERATURE CHANGES NOTED DURING THE REPROGRAMMING SESSION. IT WAS NOTED THAT AN IMPEDANCE CHECK HAD BEEN DONE AND THE RESULTS WERE WITHIN NORMAL LIMITS. IT WAS ALSO STATED THAT I TOOK ABOUT 9 HOURS TO CHARGE THE INS, WHICH WAS NOTED AS BEING TOO LONG. IT WAS NOTED THAT THE PATIENT FELT A BURNING SENSATION AT THE INS POCKET. NO NEW INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300429 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR