BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6000153-2008-00271

    MDR report key: 980790 · Received January 16, 2008

    Report

    Report Number
    6000153-2008-00271
    Event Type
    Injury
    Date Received
    January 16, 2008
    Date of Event
    May 29, 2007
    Report Date
    December 19, 2007
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    GZB
    PMA / PMN Number
    K971756
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE HCP REPORTED THE PATIENT EXPERIENCED WEAKNESS AND NUMBNESS POST SURGERY. SURGICAL EXPLORATION FOR POSSIBLE CORD COMPRESSION OCCURRED THE FOLLOWING DAY; THE LEAD WAS REPOSITIONED. THE HCP REPORTED THE PATIENT MADE GRADUAL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GZB MEDTRONIC PUERTO RICO OPERATIONS CO. 3998 V001559

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention EXTENSION MODEL 37082 LOT# NKB008148N| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTABLE NEUROSTIMULATOR| MODEL 37713 LOT# NJK701927H| IMPLANTED:| EXTENSION MODEL 37083 LOT# NKC012269N