BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 4122438 · Received September 26, 2014

    Report

    Report Number
    3004209178-2014-17812
    Event Type
    Injury
    Date Received
    September 26, 2014
    Report Date
    September 4, 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
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 748951, SERIAL# (B)(4), PRODUCT TYPEL: EXTENSION. PRODUCT ID: 3998, LOT# V004644, PRODUCT TYPE: LEAD. PRODUCT ID: 74002, LOT# N240205, PRODUCT TYPE: ADAPTER. PRODUCT ID: 748951, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN MARCH THE PATIENT HAD THEIR BATTERY REPLACED FOR THEIR STIMULATOR DUE TO END OF LIFE AND IT WAS A SIMPLE REPLACEMENT. IT WAS LATER REPORTED THAT THE PATIENT HAD SHOCKING AND JOLTING IN THE PAST AND THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED DUE TO THIS ISSUE. IT WAS FURTHER NOTED THAT NO JOLTING WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600911 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 Required Intervention