BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 2930734 · Received January 28, 2013

    Report

    Report Number
    3004209178-2013-00994
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Report Date
    January 7, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 377775, LOT# V010486, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 377775, LOT# V009841, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE RECHARGER; PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION WHEN RECHARGING HER IMPLANTABLE NEUROSTIMULATOR (INS) A COUPLE OF MONTHS PRIOR TO THE REPORT. THE REPORTER WAS UNSURE IF THE PATIENT HAD STIMULATION ON OR NOT WHEN RECHARGING, BUT STATED THAT THE PATIENT FELT 'A SURGE OF ENERGY.' SINCE THEN, STIMULATION HAD CHANGED AND IT WAS NOT COVERING WHERE IT SHOULD. HOWEVER, THE PATIENT HAD NOT FELT ANOTHER 'SURGE OF ENERGY' SINCE IT HAPPENED PREVIOUSLY. THE REPORTER INDICATED THAT THE PATIENT HAD NOT HAD ANY FALLS OR TRAUMA. ADDITIONAL INFORMATION RECEIVED TWO DAYS LATER INDICATED THAT IMPEDANCE TESTING WAS NOT DONE, NEITHER WAS THE CAUSE OF THE ISSUE DETERMINED. IT WAS NOTED THAT THE PATIENT WAS FINE AND RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36600 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1