BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3022233 · Received March 26, 2013

    Report

    Report Number
    3006630150-2013-00536
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    February 3, 2013
    Report Date
    February 4, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE DISLODGED CONTACTS WERE STILL IMPLANTED IN THE PATIENT. THE PHYSICIAN HAS DECIDED TO REMAIN THE CONTACTS IMPLANTED AND TO TAKE NO FURTHER COURSE OF ACTION.

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICES WAS NOT RETURNED TO BSN AS THEY WAS 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.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS NOT RECEIVING STIMULATION. A CT SCAN SHOWED THAT THE CONTACTS CAME OFF FROM THE PADDLE LEAD. THE CONTACTS WERE DISLODGED INSIDE THE PATIENT'S BODY. THE PATIENT UNDERWENT A LEAD REVISION WHEREIN THE LEAD WAS REPLACED. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS NOT RECEIVING STIMULATION. A CT SCAN SHOWED THAT THE CONTACTS CAME OFF FROM THE PADDLE LEAD. THE CONTACTS WERE DISLODGED INSIDE THE PATIENT'S BODY. THE PATIENT UNDERWENT A LEAD REVISION WHEREIN THE LEAD WAS REPLACED. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124659 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention