BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3171352 · Received June 14, 2013

    Report

    Report Number
    3006630150-2013-01224
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 22, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING THE PERMANENT IMPLANT PROCEDURE, THE PHYSICIAN ENTERED THE EPIDURAL SPACE WITH A NEEDLE AND WHEN THE LEADS WERE BACKED OUT, TWO CONTACTS ON THE PATIENT¿S LEAD GOT DISLODGED. THE PHYSICIAN PROCEEDED WITH THE PROCEDURE AND LEFT THE TWO CONTACTS INSIDE THE PATIENT¿S BODY. THE PATIENT WAS DOING WELL AFTER THE PROCEDURE. THERE WILL BE NO NEXT COURSE OF ACTION FOR THE UNRETRIEVED CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271254 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention