BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1 X 8 COMPACT TEST STIM LEAD

    MDR report key: 3024348 · Received March 27, 2013

    Report

    Report Number
    6000153-2013-00051
    Event Type
    Injury
    Date Received
    March 27, 2013
    Report Date
    March 12, 2013
    Manufacturer
    NEURO - VILLALBA
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 387345, LOT# V523685, IMPLANTED: 2011-(B)(6), PRODUCT TYPE SCREENING DEVICE PRODUCT ID 387345, LOT# V576756, IMPLANTED: 2011-(B)(6), PRODUCT TYPE SCREENING DEVICE PRODUCT ID 387445, LOT# V771496, IMPLANTED: 2011-(B)(6), PRODUCT TYPE SCREENING DEVICE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S DEVICE "SHORT CIRCUITED OR SOMETHING" SO THE LEAD WAS REPLACED AT SOME POINT IN (B)(6) 2011. IT WAS ALSO STATED THE DEVICE "NEVER REALLY WORKED." IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED. REFERENCE MANUFACTURER REPORTS #6000153-2013-00048, #6000153-2013-00049, AND #6000153-2013-00050.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126138 1 X 8 COMPACT TEST STIM LEAD STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW NEURO - VILLALBA 387345 V576756

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention