BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3203364 · Received July 2, 2013

    Report

    Report Number
    3006630150-2013-01345
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    April 29, 2013
    Report Date
    June 11, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE CLIK ANCHORS WERE REPLACED WITH NEW ONES. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE. 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-2218-70, SERIAL/LOT #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 70CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE LEAD SITE. THE PHYSICIAN BELIEVED THAT THE CLIK ANCHORS WERE THE CAUSE OF THE PAIN BECAUSE THEY WERE TOO HARD AND WERE RUBBING ON THE PATIENT'S SPINOUS PROCESS. THE PATIENT WILL UNDERGO A REVISION WHEREIN THE CLIK ANCHORS WILL BE REPLACED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE LEAD SITE. THE PHYSICIAN BELIEVED THAT THE CLIK ANCHORS WERE THE CAUSE OF THE PAIN BECAUSE THEY WERE TOO HARD AND WERE RUBBING ON THE PATIENT'S SPINOUS PROCESS. THE PATIENT WILL UNDERGO A REVISION WHEREIN THE CLIK ANCHORS WILL BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301087 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-4316 15252313

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention