BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1133126 · Received August 22, 2008

    Report

    Report Number
    3004209178-2008-05178
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 24, 2008
    Report Date
    July 24, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING THE IMPLANT OF TWO DEEP BRAIN STIMULATORS, THE LEAD CAPS WERE EXPOSED ON BOTH SIDES BEHIND THE EAR. WHEN EACH LEAD CAP WAS REMOVED, IT WAS APPARENT THAT THE NUMBER 3 CONTACT HAD BEEN STRETCHED DISTALLY, AND THE INSULATION WAS BROKEN ON THE PROXIMAL SIDE OF CONTACT 3. WHEN THE LEADS WERE FURTHER EXAMINED AND MANIPULATED, IT WAS NOTED THAT WIRES WERE EXPOSED DUE TO BROKEN INSULATION. THE EXACT SAME DAMAGE WAS NOTED ON BOTH LEADS. THE LEADS WERE GENTLY INSERTED INTO THE EXTENSION BLOCKS. THE HCP DID NOT NEED TO CUT THE LEADS. IMPEDANCES WERE NORMAL. THE LEADS WERE IMPLANTED. NO PATIENT PROBLEMS NOTED AFTER IMPLANT. THE TECHNIQUE OF CREATING THE SUBGALEAL POCKET AND PASSING THE LEAD/CAP WAS NORMAL. THE TECHNIQUE OF EXPOSING THE LEAD CAP WAS NORMAL. NO PROCEDURAL ERROR WAS NOTED. PLEASE SEE MFR. REPORT # 3004209178-2008-05177.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR PROGRAMMER: MODEL 7438| EXPLANTED:| LEAD: MODEL 3387| EXTENSION: MODEL 7482| EXPLANTED:| EXTENSION: MODEL 7482| EXPLANTED:| IMPLANTABLE NEURO SIMULATOR: MODEL 7426| LOT# NFW149826H| EXPLANTED:| LEAD: MODEL 3387| EXPLANTED: