BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 4201398 · Received October 27, 2014

    Report

    Report Number
    3006630150-2014-02468
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 12, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-3400-30, SERIAL #:(B)(4), DESCRIPTION:INFINION SPLITTER 2X8 KIT (30 CM) ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS AND LEAD SPLITTERS WERE EXPLANTED, AND NEW LEADS WERE IMPLANTED. THE REASON FOR THE REVISION WAS DUE TO HIGH IMPEDANCES WHICH RESULTED IN UNUSABLE CONTACTS THAT WERE NEEDED. THE PHYSICIAN BELIEVED DEVICE MALFUNCTION WAS FROM THE LEADS CONNECTION TO THE LEAD SPLITTER. THE PATIENT WAS REPORTEDLY DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS 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 COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-2316-50 SERIAL #: (B)(4), DESCRIPTION: INFINION 1X16 PERC LEAD KIT-50 CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE STIMULATION WAS CAUSING PAIN IN THE THORACIC AREA. IT WAS STATED THAT THE PAIN WAS CAUSED BY HIGH IMPEDANCES. THE PATIENT WILL UNDERGO A REVISION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE STIMULATION WAS CAUSING PAIN IN THE THORACIC AREA. IT WAS STATED THAT THE PAIN WAS CAUSED BY HIGH IMPEDANCES. THE PATIENT WILL UNDERGO A REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684676 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention