BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3043543 · Received April 9, 2013

    Report

    Report Number
    3006630150-2013-00663
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 14, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2352-50, SERIAL/LOT #: (B)(4), DESCRIPTION: LINEAR 3-4 LEAD, 50CM. 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 HAD SEVERE INFLAMMATION IN BOTH THE MIDLINE AND POCKET INCISION. THE PATIENT HAD FEVER AS WELL AS PAIN AND DRAINAGE AT THE LEAD AND IPG INCISION SITES. THE PATIENT WAS HOSPITALIZED AND WAS GIVEN INTRAVENOUS ANTIBIOTICS. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS DEVICE AND PROCEDURE RELATED. THE PATIENT WAS REPORTEDLY DOING FINE AND THE INFECTION HAS BEEN CLEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146422 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R