BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION SPECTRA®

    MDR report key: 4201328 · Received October 27, 2014

    Report

    Report Number
    3006630150-2014-02478
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    July 29, 2014
    Report Date
    July 29, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2218-70, SERIAL #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 70CM. ADDITIONAL INFORMATION WAS RECEIVED THAT DURING THE PATIENT¿S REVISION, THE LEADS WERE EXPLANTED. NO FURTHER INFORMATION CAN BE OBTAINED BY BSN. THE EXPLANTED LEADS WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. IT IS INDICATED THAT THE LEADS 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 MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-3138-25, SERIAL #: (B)(4), DESCRIPTION: SCS PHIII EXT 25CM. THE EXPLANTED DEVICES WERE NOT 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 THE PATIENT NO LONGER HAD NECK OR UPPER BACK COVERAGE. SIX CONTACTS OUT WERE NOTED. THE PATIENT UNDERWENT REVISION WHEREIN IT WAS DETERMINED THAT THE HIGH IMPEDANCES CAME FROM THE EXTENSIONS. THE EXTENSIONS WERE EXPLANTED AND THE PHYSICIAN DISCOVERED THAT HE HAD ENOUGH LEAD LENGTH TO CONNECT DIRECTLY TO THE IPG. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT NO LONGER HAD NECK OR UPPER BACK COVERAGE. SIX CONTACTS OUT WERE NOTED. THE PATIENT UNDERWENT REVISION WHEREIN IT WAS DETERMINED THAT THE HIGH IMPEDANCES CAME FROM THE EXTENSIONS. THE EXTENSIONS WERE EXPLANTED AND THE PHYSICIAN DISCOVERED THAT HE HAD ENOUGH LEAD LENGTH TO CONNECT DIRECTLY TO THE IPG. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683813 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-3138-25 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR