BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2070076 · Received April 26, 2011

    Report

    Report Number
    3006630150-2011-00576
    Event Type
    Injury
    Date Received
    April 26, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT HAD THE ENTIRE PRECISION SYSTEM EXPLANTED. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL#:SC-1110-02 SERIAL#: (B)(4) DESCRIPTION: IPG KIT WITHOUT PULL-THROUGH TUNNELER VISUAL EXPECTION OF THE IPG REVEALED NO ANOMALIES. VISUAL INSPECTION OF THE PADDLE LEAD CONFIRMED DEVICE HAS LOST ITS INTEGRITY; SEVERAL ELECTRODES WERE BROKEN OFF AND MISSING. THE SUTURES SLEEVES APPEAR NORMAL. THE ROOT CAUSE AND EXACT TIMING OF THE DAMAGE IS UNKNOWN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT DOES NOT FEEL ANY STIMULATION. AN X RAY TAKEN SHOWED THAT MULTIPLE CONTACTS ON THE PADDLE LEAD HAVE DETACHED FROM THE LEAD. THE PATIENT DOES NOT WANT TO UNDERGO A LEAD REVISION BUT INSTEAD IS IN DISCUSSIONS WITH THE PHYSICIAN TO HAVE THE PRECISION DEVICE EXPLANTED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT DOES NOT FEEL ANY STIMULATION. AN X RAY TAKEN SHOWED THAT MULTIPLE CONTACTS ON THE PADDLE LEAD HAVE DETACHED FROM THE LEAD. THE PATIENT DOES NOT WANT TO UNDERGO A LEAD REVISION BUT INSTEAD IS IN DISCUSSIONS WITH THE PHYSICIAN TO HAVE THE PRECISION DEVICE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention