BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3141290 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-08499
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    May 14, 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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3998 LOT# V601346, IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3998 LOT# V601346, IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3708260 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 3708140 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) MOVED IN THEIR ABDOMEN AREA SIX WEEKS POST IMPLANT. IT WAS STATED, THE PATIENT HAD TO GO BACK INTO SURGERY AND A POUCH WAS PLACED TO PREVENT THE INS FROM MOVING. IT WAS NOTED SINCE THE REVISION SURGERY, THE PATIENT HAD NOT HAD ANY ISSUES AND THEIR STIMULATION WAS WORKING GREAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244078 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 Required Intervention