BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3247502 · Received July 25, 2013

    Report

    Report Number
    3004209178-2013-12306
    Event Type
    Malfunction
    Date Received
    July 25, 2013
    Report Date
    July 1, 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 37651, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER, PRODUCT ID 3550-39, LOT# N231447, IMPLANTED: (B)(6) 2009. PRODUCT TYPE ACCESSORY; PRODUCT ID 3778-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: LEAD, PRODUCT ID 3778-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: LEAD, PRODUCT ID 37743, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT RECEIVED ASSISTANCE ON (B)(6) 2013 AND THE ISSUES RESOLVED. THE PATIENT STATED THAT BESIDES THE SHOCKING, THE STIMULATOR HAD NOT BEEN HITTING AREAS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PROGRAM #1 HAD CHANGED, APPROXIMATELY A MONTH PRIOR TO THE REPORT. THE PROGRAM WAS FOR HER GROIN. THE PATIENT COULD PREVIOUSLY ADJUST THE STIMULATION BETWEEN 3-5 VOLTS, BUT NOW SHE COULDN¿T GO HIGHER THAN 0.4 VOLTS AND IT WAS UNBEARABLE. THE STIMULATION FELT VERY HARSH AND POUNDING. WHEN THE PATIENT TURNED IT ON, IT SHOCKED HER, SO SHE WAS AFRAID TO USE THE PROGRAM. THE PROGRAM FOR HER BACK WAS WORKING FINE. THE PATIENT HAD NO FALL/TRAUMA, BUT HAD BEEN DOING GARDENING THAT INCLUDED BENDING. ADDITIONAL INFORMATION WAS REQUESTED; IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348696 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 00066 YR