BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3073262 · Received April 23, 2013

    Report

    Report Number
    3006630150-2013-00755
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. NO DEVICE MALFUNCTION SUSPECTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. 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-2218-50 SERIAL/LOT #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 50CM.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN DOES NOT FEEL THAT THE PATIENT¿S SYMPTOMS AND THE INJECTION WERE DEVICE RELATED. NO FURTHER ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S STIMULATION SETS OFF HER FIBROMYALGIA AND SHE GETS MORE PAIN. THE PATIENT HAD AN INJECTION AND WILL UNDERGO AN EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S STIMULATION SETS OFF HER FIBROMYALGIA AND SHE GETS MORE PAIN. THE PATIENT HAD AN INJECTION AND WILL UNDERGO AN EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S STIMULATION SETS OFF HER FIBROMYALGIA AND SHE GETS MORE PAIN. THE PATIENT HAD AN INJECTION AND WILL UNDERGO AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174292 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention