BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 1963427 · Received December 20, 2010

    Report

    Report Number
    1644487-2010-02850
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 24, 2010
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SURGEON THAT HIGH LEAD IMPEDANCE WAS REC'D IN THE OPERATING ROOM WHILE REPLACING A PT'S GENERATOR DUE TO END OF SERVICE. THE PT'S OLD GENERATOR WAS UNABLE TO BE INTERROGATED DUE TO END OF SERVICE AND HIGH IMPEDANCE WAS REC'D WHEN A NEW GENERATOR WAS PLACED ONTO THE PT'S EXISTING LEADS. THE NEW GENERATOR WAS DISCONNECTED AND TESTED WITH A TEST RESISTOR AND FOUND TO BE FUNCTIONING PROPERLY. THE PIN WAS REINSERTED AFTER VERIFYING NO DEBRIS WAS IN THE PIN RECEPTACLE. THE SURGEON THEN DECIDED TO RE-IMPLANT THE PT WITH ANOTHER GENERATOR AND REPLACE THE LEADS DUE TO THE REC'D HIGH IMPEDANCE. F/U WAS MADE WITH THE PT'S TREATING NEUROLOGIST WHO INDICATED THE PT WAS REFERRED FOR SURGERY ON (B)(6) 2010 AS INTERROGATION OF THE PT'S DEVICE INDICATED 7/LIMIT/HIGH/NO. THE LAST KNOWN GOOD DIAGNOSTICS WERE FROM (B)(6) 2009 AND WERE WITHIN NORMAL LIMITS (NO SPECIFICS) DCDC 2. NO PT MANIPULATION OR TRAUMA WAS REPORTED AND A CHEST X-RAY WAS TAKEN ON (B)(6) WHICH WOULD NOT BE RELEASED TO THE MFR. THE EXPLANTED GENERATOR AND LEAD WERE RETURNED TO THE MFR AND EXPLANTED FOR BOTH END OF SERVICE AND LEAD DISCONTINUITY. AT THE MOMENT THE EXPLANTED DEVICES ARE UNDERGOING PRODUCT ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LYJ CYBERONICS INC 300-20 38902C

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR