BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2874485 · Received December 14, 2012

    Report

    Report Number
    3006630150-2012-02394
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 8, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT POCKET REVISION WHEREIN THE IPG WAS MOVED AND EXTENSIONS WERE ADDED AWAY FROM THE SITE. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE. 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-8216-50, SERIAL #: (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 50CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD PAIN AT THE POCKET SITE WHILE BEING CONFINED IN THE HOSPITAL AFTER THE IMPLANT. IT WAS BELIEVED THAT AN INFECTION DEVELOPED WITHIN 24 HOURS AFTER THE SURGERY. THE PATIENT WAS GIVEN INTRAVENOUS VANCOMYCIN ANTIBIOTIC AND WAS DISCHARGED FROM THE HOSPITAL. THE INFECTION HAD BEEN RESOLVED. THE PATIENT WILL UNDERGO A POCKET REVISION DUE TO THE POCKET PAIN. THE PHYSICIAN BELIEVES THE IPG IS TOO SHALLOW AND HAS BEEN CAUSING PAIN UPON CHARGING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD PAIN AT THE POCKET SITE WHILE BEING CONFINED IN THE HOSPITAL AFTER THE IMPLANT. IT WAS BELIEVED THAT AN INFECTION DEVELOPED WITHIN 24 HOURS AFTER THE SURGERY. THE PATIENT WAS GIVEN INTRAVENOUS VANCOMYCIN ANTIBIOTIC AND WAS DISCHARGED FROM THE HOSPITAL. THE INFECTION HAD BEEN RESOLVED. THE PATIENT WILL UNDERGO A POCKET REVISION DUE TO THE POCKET PAIN. THE PHYSICIAN BELIEVES THE IPG IS TOO SHALLOW AND HAS BEEN CAUSING PAIN UPON CHARGING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R