BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1953750 · Received January 4, 2011

    Report

    Report Number
    3006630150-2010-02193
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    December 2, 2010
    Report Date
    December 2, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PT WOULD UNDERGO A LEAD REVISION FOR LEAD MIGRATION. DURING THE REVISION, THE PHYSICIAN DISCOVERED THAT THE LEAD HAD BEEN STRIPPED, AND DID NOT BELIEVE IT HAD OCCURRED DURING THE PROCEDURE. THE LEAD WAS REPLACED AND THE PT WAS REPORTEDLY DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention