BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOW PROFILE EXTENSION

    MDR report key: 1001736 · Received February 19, 2008

    Report

    Report Number
    6000153-2008-00786
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Date of Event
    December 17, 2007
    Report Date
    January 22, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF FINAL DEVICE ANALYSIS REVEALED THAT MULTIPLE CONDUCTOR WIRES WERE BROKEN; THE WELD WAS BROKEN AT THE CONDUCTOR COIL TO STRAIGHT WIRE (TRANSITION) CRIMP SLEEVE AT NUMBER ZERO. DEVICE INSPECTION HAD REVEALED THE PROD OUTER INSULATION WAS INTACT; THE PROXIMAL AND DISTAL ENDS APPEARED INTACT AND UNDAMAGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD EXPERIENCED A DECREASE IN THERAPY BENEFIT OVER THE PAST MONTH. DURING SURGERY TO REPLACE THE IPG AND EXTENSION PRODUCTS, THE LEAD HAD APPEARED DAMAGED (NO DETAILS WERE PROVIDED); SURGICAL REMOVAL OF THE LEAD WAS ANTICIPATED IN 2008, TIMEFRAME. THE PT HAD RECOVERED FROM THE LATE 2007, SURGERY WITHOUT SEQUELA; THE PHYSICIAN HAD ALSO PROVIDED THAT THE PT GREW FOUR INCHES WITHIN THE LAST YR. ADD'L INFO HAS BEEN REQUESTED FROM THE PHYSICIAN. REFER TO MFR REPORT #6000153200800133.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOW PROFILE EXTENSION MHY MEDTRONIC PUERTO RICO OPERATIONS CO 7482 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention IMPLANTABLE NEURO STIMULATOR MODEL 7426| IMPLANTED| IMPLANTED| PROGRAMMER MODEL 7438 LOT # NHL018830P| EXPLANTED| LOT # NFW137323H