BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3884019 · Received June 19, 2014

    Report

    Report Number
    3006630150-2014-01389
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    October 17, 2013
    Report Date
    October 17, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG AND LEADS WERE REPLACED. ONE LEAD HAD TWO BAD CONTACTS. THE PATIENT WAS DOING WELL AFTER THE PROCEDURE. THE PHYSICIAN BELIEVED THE PAIN WAS NOT CAUSED BY THE DEVICE. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE 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

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2352-70, SERIAL #: (B)(4), DESCRIPTION: LINEAR 3-4 LEAD, 70CM. MODEL #: SC-1110-02, SERIAL #: (B)(4), DESCRIPTION: PRECISION IMPLANTABLE PULSE GENERATOR.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED SHARP PAINS WHEN THE STIMULATION WAS ON. THE PATIENT WILL UNDERGO A REVISION PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED SHARP PAINS WHEN THE STIMULATION WAS ON. THE PATIENT WILL UNDERGO A REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360425 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2352-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention