BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 6190183 · Received December 20, 2016

    Report

    Report Number
    3006630150-2016-03849
    Event Type
    Injury
    Date Received
    December 20, 2016
    Date of Event
    October 25, 2013
    Report Date
    December 8, 2016
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-3138-25, SERIAL # (B)(4), DESCRIPTION: SCS PHIII EXT 25CM. IT IS INDICATED THAT THE DEVICES WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICES 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 THE PATIENT¿S LEAD OF THE UPPER LIMB (CERVICAL SPINE) WAS INFECTED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE PHYSICIAN EXPLANTED AND REPLACED ONE OF THE LEADS AND THE LEAD EXTENSIONS. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841478 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 NA 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention