BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSION-1X8

    MDR report key: 1950358 · Received December 14, 2010

    Report

    Report Number
    6000153-2010-10425
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 4, 2011
    Manufacturer
    MPROC, VILLALBA
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE ANALYSIS WAS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN DEVICE ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE TUNNELING TOOL FOUND THAT THE HANDLE WAS BROKEN. THE TUNNELING TOOL WAS RECEIVED WITH THE OBTURATOR STILL IN THE TUNNELING TOOL AND THE HANDLE OF THE TUNNELING TOOL BROKEN. THERE WAS DAMAGE ON THE OBTURATOR SHAFT AT THE LOCATION OF THE BREAK IN THE HANDLE. ANALYSIS INDICATED THAT THE HANDLE LIKELY BROKE UNDER SHEAR CONDITIONS (IMPACTED AGAINST A HARD SURFACE). SAMPLE TUNNELING TOOLS WERE BROKE IN SHEAR MODE, BENDING, TENSILE IMPACT AND COMPRESSION IMPACT. COMPARISON OF THE BROKEN SAMPLES WITH THE BROKEN RETURNED TUNNELING TOOL INDICATED THAT THE BREAKAGE MOST CLOSELY MATCHED A BREAK THAT OCCURRED UNDER SHEAR. IT COULD NOT BE DETERMINED WHEN THE BREAKAGE ACTUALLY OCCURRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE TUNNELING TOOL WAS BROKEN IN THE PACKAGE. AN ALTERNATE TUNNELING TOOL WAS USED. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENSION-1X8 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MPROC, VILLALBA 37081

    Patients

    Seq Age Sex Outcome Treatment
    1 STIM ACCESSORY: MODEL TUNNELING TOOL, LOT# UNK