BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1926267 · Received November 11, 2010

    Report

    Report Number
    3007566237-2010-09249
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 25, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY TO REPLACE AN IMPLANTABLE NEUROSTIMULATOR (INS), IMPEDANCE READINGS ON THE NEW INS WERE >10,000 OHMS. PRIOR TO SURGERY IMPEDANCES WERE WITHIN THE NORMAL RANGE. WHEN THE EXTENSIONS WERE DISCONNECTED FROM THE OLD INS AND INSERTED INTO THE NEW INS, CONTACT 8-11 HAD IMPEDANCES >10,000 OHMS. UPON CLEANING AND RETESTING AT A HIGHER VOLTAGE, IMPEDANCE READINGS WERE >20,000 OHMS. THE EXTENSION FROM THE 0-7 PORT WAS TRIED IN THE 8-11 PORT WITH CONTINUED HIGH IMPEDANCE READINGS IN 8-11. THE INS WAS NOT IMPLANTED AND A THIRD INS WAS USED WITH IMPEDANCE READINGS WITHIN NORMAL RANGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MEDTRONIC NEUROMODULATION 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR MODEL 37713, LOT# NJK703819H| IMPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD044221N| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37083, LOT# NKC011996N| IMPLANTED:| IMPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA029283N| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37083, LOT# NKC012272N| LEAD: MODEL 3998, LOT# V026436| EXPLANTED:| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: