BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION

    MDR report key: 1921206 · Received December 9, 2010

    Report

    Report Number
    3006630150-2010-02111
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 10, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A LEAD REVISION PROCEDURE DUE TO LEAD MIGRATION IT WAS NOTED THAT CONTACT 6 WAS BENT AND CONTACT 1 WAS NOT WORKING. THE LEAD WAS EXPLANTED AND A NEW LEAD IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2158-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK