BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA

    MDR report key: 7003737 · Received November 6, 2017

    Report

    Report Number
    3006630150-2017-04362
    Event Type
    Injury
    Date Received
    November 6, 2017
    Date of Event
    October 16, 2017
    Report Date
    October 16, 2017
    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

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2208-70 SERIAL #: (B)(4), DESCRIPTION: ST LINEAR LEAD 70CM; MODEL #: SC-2218-50 SERIAL #: (B)(4), DESCRIPTION: LINEAR ST LEAD,50CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE MIDLINE INCISION SITE. THE PATIENT UNDERWENT A LEAD SITE REVISION PROCEDURE. NO DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782998 PRECISION SPECTRA SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2208-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention