BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2955739 · Received February 11, 2013

    Report

    Report Number
    3006630150-2013-00247
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 22, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE ENTIRE SYSTEM WAS EXPLANTED DUE TO A COMPLETE FRACTURE OF THE INFINION LEAD IN THE SPLITTER HEAD. THE PATIENT WAS HOSPITALIZED DUE TO VOMITING WHICH MAY CAUSED BY THE LEAD BREAKAGE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2316-50, SERIAL #: (B)(4), DESCRIPTION: INFINION 1X16 PERC LEAD KIT-50CM.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT THE PROXIMAL END OF THE LEAD WAS BROKEN OFF IN THE DISTAL CONNECTOR OF THE SPLITTER WAS CONFIRMED BY VISUAL AND X-RAY INSPECTION. THE LEAD WAS SEVERED APPROXIMATELY 2 INCHES FROM THE PROXIMAL END. THIS APPEARS TO HAVE BEEN CAUSED BY FATIGUE POSSIBLY COUPLED WITH POSTURAL CHANGES/MOVEMENTS. NO FAILURE WAS VERIFIED REGARDING THE ASSOCIATED IPG OR SPLITTER.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING HIGH IMPEDANCES DUE TO A SPLITTER BEING DISLODGED FROM THE LEAD AND THE PATIENT WILL UNDERGO A REPLACEMENT OF SPLITTER AND LEAD.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING HIGH IMPEDANCES DUE TO A SPLITTER BEING DISLODGED FROM THE LEAD AND THE PATIENT WILL UNDERGO A REPLACEMENT OF SPLITTER AND LEAD.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING HIGH IMPEDANCES DUE TO A SPLITTER BEING DISLODGED FROM THE LEAD AND THE PATIENT WILL UNDERGO A REPLACEMENT OF SPLITTER AND LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59490 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-3400-30 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization| R