BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2935213 · Received January 30, 2013

    Report

    Report Number
    3004209178-2013-01111
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Report Date
    January 10, 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 MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002. PRODUCT TYPE: UNKNOWN: PRODUCT ID 74001, LOT# N231703, IMPLANTED: (B)(6) 2010. PRODUCT TYPE: ADAPTER: PRODUCT ID 3887-28, LOT# J0208322V, IMPLANTED: (B)(6) 2002. PRODUCT TYPE: LEAD: PRODUCT ID 37752, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 37743, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2013 A PATIENT HAD HER STIMULATION ON AND WENT UNDER ELECTRICAL TOWERS AND FELT A JOLT. SHE TURNED THE STIMULATION OFF AND BACK ON WITHOUT ISSUES. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40427 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 00061 YR