BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 3532279 · Received December 23, 2013

    Report

    Report Number
    3006630150-2013-02818
    Event Type
    Injury
    Date Received
    December 23, 2013
    Date of Event
    November 19, 2013
    Report Date
    November 26, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-8216-70, SERIAL/LOT #: (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 70CM; MODEL #: SC-8216-50, SERIAL/LOT #: (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 50CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO A PROCEDURE RELATED INFECTION AT THE IPG AND MIDLINE INCISION SITES. SYMPTOMS INCLUDED REDNESS, FEVER AND DRAINAGE AT BOTH THE IPG AND MIDLINE INCISION SITES. THE PATIENT WAS ADMINISTERED WITH ORAL ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671862 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention