BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION SPECTRA®

    MDR report key: 4112351 · Received September 24, 2014

    Report

    Report Number
    3006630150-2014-02178
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL#: SC-2218-70 SERIAL #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 70CM THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE KEPT 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

    (B)(4). ADDITIONAL INFORMATION WAS RECEIVED THAT THE LEFT SIDE LEAD SHOWED SUPER HIGH IMPEDANCE AND THE PHYSICIAN SUSPECTED MALFUNCTION OF THE LEAD.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S LEFT SIDE LEAD WAS NONFUNCTIONING. THE PATIENT UNDERWENT A REVISION WHEREIN THE LEADS WERE REPLACED. THE PATIENT WAS REPORTEDLY DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD A LOT OF PAIN IN THE BACK AND THE LEFT SIDE LEAD WAS NONFUNCTIONING. THE PATIENT UNDERWENT A REVISION WHEREIN THE LEADS WERE REPLACED. THE PATIENT WAS REPORTEDLY DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596085 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention