BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3597856 · Received January 29, 2014

    Report

    Report Number
    3007566237-2014-00324
    Event Type
    Injury
    Date Received
    January 29, 2014
    Report Date
    January 12, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    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

    PRODUCT ID 37712, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 37752, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 39286-65, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37743, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE RECHARGER PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37711, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 355029, LOT# N060623, IMPLANTED: 2006 (B)(6); PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT¿ IMPLANTABLE NEUROSTIMULATOR (INS) WAS NOT PLACED RIGHT AND THAT SHE COULD NOT GET THE STIMULATION WHERE SHE NEEDED IT. IT WAS NOTED, THE INS WAS REPLACED IN 2010. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63534 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention