BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1950098 · Received December 7, 2010

    Report

    Report Number
    1644487-2010-02739
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 9, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT A VNS PT WAS REFERRED FOR GENERATOR REPLACEMENT SURGERY AS HER TREATING NEUROLOGIST STATED THE PT'S BATTERY WAS DEAD. ADD'L INFO WAS RECEIVED THROUGH A COMPANY REP INDICATING THE PT WAS INTERROGATED BY THE TREATING NEUROLOGIST PRIOR TO REFERRAL FOR SURGERY AND HIGH LEAD IMPEDANCE WAS ENCOUNTERED (7/LIMIT/HIGH). PER THE TREATING NEUROLOGIST, THE PT HAD BEEN EXPERIENCING A SLIGHT INCREASE IN SEIZURE ACTIVITY AND FELT IT WAS RELATED TO THE HIGH LEAD IMPEDANCE AS THE INCREASE WAS BELOW PRE-VNS BASELINE. FURTHER INFO WAS RECEIVED FROM ANOTHER COMPANY PRESENT AT THE TIME OF SURGERY. THE COMPANY REP INDICATED PRE-OP DIAGNOSTICS WERE LIMIT/HIGH/7/NO. THE SURGEON DID NOT NOTE A GROSS LEAD CONTINUITY DURING EXPLANT, BUT DID SEE A SHARP BEND IN THE LEAD WIRE IN THE EXCESS LEAD PLACED NEAR THE GENERATOR. THE SURGEON STATED THE SILICONE APPEARED ABRADED IN THIS AREA. THE OLD LEADS WERE COMPLETELY REMOVED AND NEW LEADS PLACED IN THE SAME GENERAL ARE. TESTING WITH NEW SYSTEM WAS OK/1661 OHMS/10 YRS (OUTSIDE POCKET) AND OK/1598 OHMS/10 YRS (INSIDE). THE TREATING NEUROLOGIST CAME INTO OPERATING ROOM AND TURNED NEW GENERATOR ON TO LOW SETTINGS TO BEGIN RAMPING BACK UP. PER THE MFR'S PROGRAMMING HISTORY DATABASE, THE LAST KNOWN GOOD SYSTEM DIAGNOSTICS WERE FROM (B)(6) 2009 AND WERE WITHIN NORMAL LIMITS (OK/OK/1/NO). THE EXPLANTED GENERATOR AND LEAD WERE RETURNED TO THE MFR AND ARE CURRENTLY UNDERGOING PRODUCT ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 011114

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention