BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3972200 · Received July 31, 2014

    Report

    Report Number
    3006630150-2014-01748
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    February 5, 2014
    Report Date
    February 5, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-8216-70, SERIAL/LOT #: (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 70CM.

    Additional Manufacturer Narrative · 1

    SC-1110-02 (SN (B)(4)) DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL, ELECTRICAL, AND PERFORMANCE TESTS PERFORMED. THE IPG REVEALED NO ANOMALIES. SC-8216-70 (SN (B)(4)) DEVICE EVALUATION INDICATED THAT THE LEAD PASSED PHOTOGRAPHIC IMAGING TEST PERFORMED. THE LEAD BODY WAS CUT, AND ONLY TWO PROXIMAL ENDS WERE RETURNED. NO FOUND ANOMALIES ON THE PROXIMAL ENDS. THE DAMAGE WAS A RESULT OF A TYPICAL EXPLANT PROCEDURE, AND IT WAS NOT CONSIDERED A FAILURE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE REGARDING THE EXPLANT PROCEDURE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT NO FURTHER COURSE OF ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING POCKET PAIN WITH OCCASIONAL SWELLING. THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING POCKET PAIN WITH OCCASIONAL SWELLING. THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING POCKET PAIN WITH OCCASIONAL SWELLING. THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING POCKET PAIN WITH OCCASIONAL SWELLING. THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447968 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention