BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRA

    MDR report key: 4152966 · Received October 8, 2014

    Report

    Report Number
    3006630150-2014-02113
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-4316, LOT #: 16377029, DESCRIPTION: NEXT GENERATION ANCHOR, KIT-STERILE; MODEL #: SC-2218-70, SERIAL #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 70CM. VISUAL AND X-RAY INSPECTIONS REVEALED: LEAD SC-2218-70 (SN (B)(4)); ALL CABLES WERE FRACTURED AT THE CLICK ANCHOR SITE. LEAD SC-2218-70(SN (B)(4)); FOUR CABLES WERE FRACTURED AT THE CLIK ANCHOR SITE. LEADS SC-2218-70 (SN (B)(4)); REVEALED NO ANOMALIES. THE LEADS PASSED ELECTRICAL, PHOTOGRAPHIC AND VISUAL TESTING. - ALL FOUR CLIK ANCHORS HAD DAMAGED EYELETS. EACH CLIK ANCHOR IS MISSING A PORTION OF THE DAMAGED EYELETS. THE SMALL PIECES OF SILICONE WERE NOT RETURNED TO BSN. NO PIECES OF THE CLIK ANCHOR WERE LEFT INSIDE THE PATIENT.

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL AND X-RAY INSPECTIONS REVEALED: LEAD SC-2218-70 (SN 430163); ALL CABLES WERE FRACTURED AT THE CLICK ANCHOR SITE. LEAD SC-2218-70 (SN (B)(4)); FOUR CABLES WERE FRACTURED AT THE CLIK ANCHOR SITE. LEADS SC-2218-70 ((B)(4)); REVEALED NO ANOMALIES. THE LEADS PASSED ELECTRICAL, PHOTOGRAPHIC AND VISUAL TESTING. ALL FOUR CLIK ANCHORS HAD DAMAGED EYELETS. EACH CLIK ANCHOR IS MISSING A PORTION OF THE DAMAGED EYELETS. THE SMALL PIECES OF SILICONE WERE NOT RETURNED. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-4316, LOT #: 16377029, DESCRIPTION: NEXT GENERATION ANCHOR, KIT-STERILE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING A LEAD REVISION PROCEDURE DUE TO LEAD MIGRATION AND HIGH IMPEDANCES, THE LEADS WERE RETURNED, ANALYZED AND FOUND TO BE BROKEN. IN ADDITION, THE CLIK ANCHORS HAD DAMAGED EYELETS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING A LEAD REVISION PROCEDURE DUE TO LEAD MIGRATION AND HIGH IMPEDANCES, THE LEADS WERE RETURNED, ANALYZED AND FOUND TO BE BROKEN. IN ADDITION, THE CLIK ANCHORS HAD DAMAGED EYELETS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632220 SPECTRA SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1