BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 5153928 · Received October 15, 2015

    Report

    Report Number
    3004209178-2015-20753
    Event Type
    Malfunction
    Date Received
    October 15, 2015
    Report Date
    September 21, 2015
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37082-20, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE:EXTENSION. PRODUCT ID: 3487A-56, LOT# V062324, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. (B)(4)

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THEY HAD TO DISCONTINUE THE USE OF THEIR STIMULATOR AFTER COLLIDING WITH A FAMILY MEMBER SKIING. THE STIMULATOR BEGAN TO BE UNBEARABLE. THE CLINICAL PROGRAMMER WAS UNABLE TO READ THE DEVICE. THE PATIENT HAD NOT CHARGED THE BATTERY SINCE (B)(6) 2015. THE DEVICE WAS NOT BEING USED AT THE TIME OF THE REPORT AND THE PATIENT HAD BEEN INSTRUCTED TO CHARGE THE BATTERY SO THAT IT COULD BE READ. THERE WERE NO SURGICAL INTERVENTIONS PLANNED. OTHER RELEVANT MEDICAL HISTORY INCLUDES OTHER CHRONIC INTRACT PAIN (TRUNK/LIMBS). NO INTERVENTIONS OR OUTCOME WERE 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685634 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 00049 YR