BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DBS LEAD (WITH STIMLOC KIT)

    MDR report key: 1052528 · Received May 22, 2008

    Report

    Report Number
    2182207-2008-02754
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 22, 2008
    Report Date
    April 22, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    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

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NUMBER THREE ELECTRODE CONTACT HAD APPEARED FRAYED OR DAMAGED AFTER REMOVAL OF THE ACCESSORY LEAD CAP COVER DURING THE CASE. EXPOSED WIRES SEEN IN THE AREA CONTACTED BY THE CAP AND THE DISTAL TIP MATERIAL HAD APPEARED STRETCHED. THE LEAD HAD SEPARATED EASILY FROM THE TEMPORARY CAP DURING THE STAGE II PROCEDURE; THE SURGEON HAD FOLLOWED MANUFACTURER INSTRUCTIONS FOR USE. THE LEAD DAMAGE HAD BEEN ATTRIBUTED TO USE OF THE TEMPORARY LEAD CAP. THE LEAD WAS SUBSEQUENTLY INSERTED INTO THE EXTENSION AND THE SYSTEM CONNECTED AFTER THE SURGEON CUT-OFF THE #3 CONTACT IN ORDER TO ATTACH THE EXTENSION AND CONNECT THE SYSTEM. POST-OPERATIVE IMPEDANCE READINGS OBTAINED SHOWED ALL UNIPOLAR ELECTRODE PAIRS WERE BETWEEN 830 AND 840 OHMS, AT 37 TO 39 USEC AND A SHORT CIRCUIT WAS SUSPECTED. ADD'L IMPEDANCE DATA OBTAINED AT 3V, SHOWED VALUES IN THE MID-500 RANGE. NO PT SYMPTOMS OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DBS LEAD (WITH STIMLOC KIT) MHY MEDTRONIC NEUROMODULATION 3389S UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 PROGRAMMER MODEL UNK LOT# UNK| IMPLANTABLE PULSE GENERATOR MODEL UNK LO# UNK| IMPLANTED:| EXPLANTED:| EXTENSION MODEL UNK MVD LOT# UNK| IMPLANTED:| EXPLANTED: