BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1943738 · Received December 21, 2010

    Report

    Report Number
    3006630150-2010-02188
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    November 28, 2010
    Report Date
    November 29, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED IPG WAS NOT RETURNED TO BSN BECAUSE, THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS REC'D THAT THE PT WAS EXPLANTED DUE TO INFECTION AT THE CERVICAL IMPLANT SITE. THE PT'S SYMPTOMS WERE REDNESS AND DRAINAGE AT THE SITE. THE PHYSICIAN DID NOT KNOW IF THE INFECTION WAS DEVICE OR PROCEDURE RELATED. THE PT WAS HOSPITALIZED FOR SIX DAYS AND PRESCRIBED ORAL AND IV ANTIBIOTICS. THE PT IS REPORTEDLY DOING FINE NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R