BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2831328 · Received November 14, 2012

    Report

    Report Number
    3006630150-2012-02140
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 1, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-1110-02, SERIAL #: (B)(4), DESCRIPTION: PRECISION, IMPLANTABLE PULSE GENERATOR (IPG) MODEL #: SC-2218-70, SERIAL #: (B)(4), DESCRIPTION: LINEAR ST, LEAD, 70CM MODEL #: SC-4316, LOT #: 15208105, DESCRIPTION: NEXT GENERATION ANCHOR KIT-STERILE IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO INFECTION. THE PATIENT SYMPTOM INCLUDED DRAINAGE AT THE MIDLINE INCISION. THE PATIENT'S INCISION SITES WERE FLUSHED WITH AN ANTIBIOTIC SOLUTION. THE PHYSICIAN DOES NOT BELIEVED THAT THE INFECTION WAS DEVICE OR PROCEDURE RELATED. THE PATIENT WAS SENT HOME WITH ANTIBIOTICS AND WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention