BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 1111640 · Received August 13, 2008

    Report

    Report Number
    3004209178-2008-04918
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 16, 2008
    Report Date
    July 16, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DURING LEAD PLACEMENT SURGERY, BOTH LEADS WERE PASSED WITH A KELLY INSTRUMENT TO A SUBGALEAL POCKET SUPERIOR AND POSTERIOR TO THE EAR. LEAD CAPS WERE PLACED ON THE LEADS FOR THE TIME BETWEEN THE LEAD PLACEMENT AND IMPLANTATION OF THE PULSE GENERATOR. ALL SURGICAL PROCEDURES DURING LEAD PLACEMENT WERE DONE BY THE SURGEON; OTHER IMPLANT DETAILS WERE NOT AVAILABLE. ALL THE DEEP BRAIN STIMULATOR IMPLANT A WEEK LATER, THE LEAD CAPS WERE EXPOSED AND DISASSEMBLED. THE LEAD INSULATION AROUND THE DISTAL PART OF THE LEFT LEAD HAD BEEN DAMAGED. RAW WIRES WERE EXPOSED AND THE NUMBER 3 CONTACT WAS DESTROYED. THE DAMAGE TO THE LEAD APPEARED TO STRETCH THE CONTACT OUT OF PLACE, RATHER THAN CRUSHING IT, CAUSING INSULATION DAMAGE AND EXPOSING THE WIRES. THE SPACING BETWEEN CONTACTS 0-2 WAS NOT AFFECTED. THE SURGEON MADE THE DECISION TO CUT THE NUMBER 3 CONTACT OFF OF THE LEAD AND INSERT THE REMAINING CONTACTS INTO THE EXTENSION. AFTER TRIMMING THE LEAD, CONTACTS 0-2 LINED UP APPROPRIATELY INSIDE THE EXTENSION AND THE IMPEDANCES SEEMED TO CONFIRM THAT THERE WAS A COMPLETE CIRCUIT. WHEN THE LEAD CAP WAS DISASSEMBLED FOR THE RIGHT BRAIN LEAD, A FRACTURE IN THE INSULATION WAS NOTED PROXIMAL TO THE NUMBER 3 CONTACT, BUT THE EXTENT OF THE DAMAGE WAS NOT AS SEVERE AS THE OTHER LEAD. NO RAW WIRES WERE NOTICEABLY EXPOSED AND THE NUMBER 3 CONTACT LOOKED TO BE IN ACCEPTABLE CONDITION, SO THE SURGEON MADE THE DECISION TO CONNECT THE LEAD AND EXTENSION IN A NORMAL FASHION. ALL IMPEDANCES SEEMED TO BE NORMAL. NO PATIENT SYMPTOMS WERE REPORTED. A F/U REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 7428 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR MODEL: PROGRAMMER, LOT UNK| IMPLANTED:| EXTENSION: MODEL: 7482, LOT NHU181890V| IMPLANTED:| LEAD: MODEL: 3389, LOT V078937| EXTENSION: MODEL: 7482, LOT NHU181887V| LEAD: MODEL: 3389, LOT V067936| IMPLANTED:| IMPLANTED: