BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2822553 · Received November 7, 2012

    Report

    Report Number
    3006630150-2012-02033
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 15, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL:2366-70, SERIAL: (B)(4), DESCRIPTION: LINEAR ST LEAD, 70CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S LEAD HAD MIGRATED AND WAS CAUSING PAIN. THE PHYSICIAN BELIEVED THAT THE LEAD WAS IRRITATING A NERVE ROOT. THE PATIENT UNDERWENT A LEAD REVISION AND THE PHYSICIAN REPLACED THE LEAD. THE PHYSICIAN DID NOT SUSPECT MALFUNCTION. THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention