BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2921199 · Received January 17, 2013

    Report

    Report Number
    3006630150-2013-00074
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 19, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE PADDLE LEAD WAS REPLACED DUE TO IT BEING BROKEN AND TWISTED WHILE THE IPG WAS REPLACED PER PHYSICIAN¿S PREFERENCE. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE. DEVICE EVALUATION INDICATED THAT THE PADDLE LEAD BODIES ARE SEVERELY TANGLED AND TWISTED. THE COMPLAINT OF THE FOUR DAMAGED CONTACTS ON THE PADDLE LEAD WAS NOT CONFIRMED. THE PADDLE END PORTION OF THE LEAD WAS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT NO FURTHER COURSE OF ACTION WILL BE TAKEN AT THIS TIME. 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 COULD ONLY FEEL STIMULATION IN THE HIP AND BUTTOCK AND NOT IN THE LEGS. X-RAY WAS DONE AND SHOWED THAT THE PADDLE LEAD WAS BROKEN AND THAT THE BOTTOM FOUR CONTACTS MOVED FROM THE PADDLE. THE PATIENT WILL UNDERGO A LEAD REVISION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT COULD ONLY FEEL STIMULATION IN THE HIP AND BUTTOCK AND NOT IN THE LEGS. X-RAY WAS DONE AND SHOWED THAT THE PADDLE LEAD WAS BROKEN AND THAT THE BOTTOM FOUR CONTACTS MOVED FROM THE PADDLE. THE PATIENT WILL UNDERGO A LEAD REVISION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT COULD ONLY FEEL STIMULATION IN THE HIP AND BUTTOCK AND NOT IN THE LEGS. X-RAY WAS DONE AND SHOWED THAT THE PADDLE LEAD WAS BROKEN AND THAT THE BOTTOM FOUR CONTACTS MOVED FROM THE PADDLE. THE PATIENT WILL UNDERGO A LEAD REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27027 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8120-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention