BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2884084 · Received December 21, 2012

    Report

    Report Number
    3006630150-2012-02433
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 30, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL: SC-1110, SERIAL: (B)(4), DESCRIPTION: IMPLANTABLE PULSE GENERATOR (IPG); MODEL: SC-3138-35, SERIAL: (B)(4), DESCRIPTION: SCS PHIII EXT 35CM. THE EXPLANTED DEVICES WILL NOT BE RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. IT IS INDICATED THAT THE DEVICES WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICES 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 SOON FOLLOWING A REVISION DUE TO HIGH IMPEDANCES, THE PATIENT EXPERIENCED A DEVICE RELATED INFECTION AROUND THE LEADS WITH DRAINAGE. INTRAVENOUS ANTIBIOTICS WERE ADMINISTERED AND THE ENTIRE SCS SYSTEM WAS EXPLANTED. THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT SOON FOLLOWING A REVISION DUE TO HIGH IMPEDANCES (MFR REPORT #: 3006630150-2012-01622), THE PATIENT EXPERIENCED A DEVICE RELATED INFECTION AROUND THE LEADS WITH DRAINAGE. INTRAVENOUS ANTIBIOTICS WERE ADMINISTERED AND THE ENTIRE SCS SYSTEM WAS EXPLANTED. THE PATIENT IS 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-8216-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention