BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2800763 · Received October 22, 2012

    Report

    Report Number
    3006630150-2012-01917
    Event Type
    Injury
    Date Received
    October 22, 2012
    Date of Event
    September 27, 2012
    Report Date
    September 27, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2208-50, SERIAL #S: (B)(4), DESCRIPTION: ST LINEAR LEAD 50CM. MODEL #: SC-2208-70, SERIAL #S: (B)(4), DESCRIPTION: ST LINEAR LEAD 70CM. MODEL #: SC-3138-35, SERIAL #S: (B)(4), DESCRIPTION: SCS PHIII EXT 35CM. EXPLANTED DEVICES WILL NOT BE RETURNED TO BSN AS IT WAS DISCARDED BY 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.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO AN INFECTION AT THE IPG SITE. THE PATIENT'S POCKET SITE OPENED AFTER THE PATIENT HAD A NON-DEVICE RELATED FALL. THE PATIENT WAS ADMINISTERED ORAL ANTIBIOTICS. THE PHYSICIAN DOES NOT BELIEVE THE INFECTION WAS DEVICE OR PROCEDURE RELATED. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R