BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 2000349 · Received February 18, 2011

    Report

    Report Number
    3004209178-2011-01226
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    February 2, 2009
    Report Date
    February 2, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    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

    INTRAOPERATIVE IMPEDANCE TESTING REVEALED IMPEDANCES READINGS GREATER THAN 3600 OHMS ON ALL ELECTRODES EXCEPT #8 OF THE RIGHT LEAD. THE PATIENT DID NOT FEEL ANY STIMULATION WHEN THE AMPLITUDE WAS INCREASED TO MAXIMUM LEVELS USING THE AFFECTED LEVELS. STIMULATION WAS FELT THROUGH THE #8 ELECTRODE. TWO DAYS LATER IMPEDANCES WERE STILL GREATER THAN 3600 OHMS. THE PATIENT WAS FINE. THE SURGEON DID A REVISION SURGERY. REVISION SURGERY WAS SUCCESSFUL. FOUR MORE LEADS AND A NEW IMPLANTABLE NEUROSTIMULATOR WERE PLACED. THE PATIENT HAD BETTER PAIN RELIEF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGABLE NEUROSTIMULATOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention IMPLANTED:| EXPLANTED:| SCREENER: MODEL ENS, LOT# UNKNOWN| IMPLANTED:| LEAD: MODEL 3777, LOT# V047815023| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE119857N| LEAD: MODEL 3777, LOT# V047815022| ACCESSORY: MODEL 37752, LOT# NKA119283N| EXPLANTED:| EXPLANTED: