BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3121045 · Received May 20, 2013

    Report

    Report Number
    3006630150-2013-00987
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 24, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2138-50 SERIAL/LOT #: (B)(4)/A34320 DESCRIPTION: SCS 50CM III LEAD. 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 INFECTION AT THE POCKET SITE. THE PHYSICIAN BELIEVED THERE WAS NOTHING WRONG WITH THE DEVICE. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE. NO FURTHER INFORMATION WILL BE PROVIDED TO BSN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221573 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention