BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3347849 · Received September 13, 2013

    Report

    Report Number
    3004209178-2013-16222
    Event Type
    Injury
    Date Received
    September 13, 2013
    Report Date
    August 20, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37743 LOT# SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 377860 LOT# V013243, IMPLANTED: 2010 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37752 LOT# SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 377860 LOT# V013243, IMPLANTED: 2010 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    THE LOCATION OF THE INS WAS CAUSING THE PATIENT PAIN. THE INS WAS ORIGINALLY IMPLANTED BY THE PHYSICIAN USING A SINGLE INCISION IMPLANT TECHNIQUE WHICH LEFT THE INS JUST RIGHT OF THE SPINOUS PROCESS. THE DEVICE HAD BEEN IRRITATING THE PATIENT SINCE SHORTLY AFTER IMPLANT. THE PATIENT UNDERWENT SURGICAL INTERVENTION AND THE INS WAS RELOCATED TO THE RIGHT BUTTOCKS. IT WAS NOTED THAT IMPEDANCE TESTING WAS DONE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462823 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 00053 YR Required Intervention