BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 3094017 · Received May 6, 2013

    Report

    Report Number
    3006630150-2013-00900
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    July 13, 2012
    Report Date
    April 11, 2013
    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-2138-70, SERIAL/LOT#: (B)(4), DESCRIPTION: LINEAR LEAD, 70 CM WITH PRE-LOADED 0.012 INCH STYLET.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING AN INCREASE IN THEIR PAIN AND WAS EXPLANTED. THE PATIENT REPORTEDLY DOING WELL. THE PHYSICIAN BELIEVES THE PATIENT'S INCREASE IN PAIN IS DUE TO THE TETHERING OF THE LEADS IN RELATION TO THE PATIENT'S EXTENSIVE PAST ABDOMINAL SURGERIES WHERE THERE ARE MANY ADHESIONS PULLING ON THE LEADS. 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.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO AN EXPLANT OF THE LEADS DUE TO HIGH IMPEDANCES. THE PHYSICIAN BELIEVES THE LEADS ARE THETHERING AND WILL CONTINUE TO DETERIORATE UNTIL THEY NEED TO BE REPLACED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO AN EXPLANT OF THE LEADS DUE TO HIGH IMPEDANCES. THE PHYSICIAN BELIEVES THE LEADS ARE THETHERING AND WILL CONTINUE TO DETERIORATE UNTIL THEY NEED TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196645 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2138-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1