BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 3435015 · Received October 29, 2013

    Report

    Report Number
    3004209178-2013-19813
    Event Type
    Injury
    Date Received
    October 29, 2013
    Report Date
    October 8, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 377845, LOT# V001578, PRODUCT TYPE: LEAD. PRODUCT ID: 3708160, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD THEIR SYSTEM REPLACED BECAUSE IT WAS ¿BROKEN.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555114 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Required Intervention