BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SC-1110-02

    MDR report key: 3580092 · Received January 16, 2014

    Report

    Report Number
    3006630150-2014-00118
    Event Type
    Injury
    Date Received
    January 16, 2014
    Date of Event
    December 20, 2013
    Report Date
    December 20, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED IPG WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY. 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS SUSPECTED TO HAVE A FLUID BUILDUP. THE PATIENT ALSO EXPERIENCED POCKET HEATING AND SORENESS. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG WAS EXPLANTED AND REPLACED WITH A NEW ONE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS SUSPECTED TO HAVE A FLUID BUILDUP. THE PATIENT ALSO EXPERIENCED POCKET HEATING AND SORENESS. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG WAS EXPLANTED AND REPLACED WITH A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43352 SC-1110-02 SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention