BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NCP PULSE GENERATOR

    MDR report key: 574024 · Received February 17, 2005

    Report

    Report Number
    1644487-2005-00116
    Event Type
    Injury
    Date Received
    February 17, 2005
    Report Date
    January 18, 2005
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    VNS PT'S DEVICE WAS PROGRAMMED TO OFF PER THEIR FAMILY'S REQUEST SEVERAL YEARS AGO DUE TO INTRACTABLE VOMITING. IT WAS REPORTED THAT THE SYMPTOMS CONTINUED AFTER THE DEVICE WAS PROGRAMMED TO CFF. THE PT WAS SEEN BY A DIFFERENT NEUROLOGIST YEARS LATER TO PROGRAM THE DEVICE BACK ON ON, AT WHICH TIME THE PHYSICIAN WAS UNABLE TO COMMUNICATE WITH THEIR DEVICE. REVIEW OF MANUFACTURING RECORDS FOR BOTH THE PULSE GENERATOR AND THE BIPOLAR LEAD REVEALED NO ANOMALIES THAT WOULD ADVERSELY EFFECT DEVICE PERFORMANCE. INVESTIGATION TO DATE HAS BEEN UNABLE TO DETERMINE THE CAUSE OF THE VOMITING OR THE COMMUNICATION DIFFICULTIES.

    Description of Event or Problem · 1

    FURTHER FOLLOW-UP REVEALED THAT THE PT COMPLAINED THAT THE DEVICE IS TENDER WHEN HE IS SLEEPING AS WELL AS TENDER TO THE TOUCH. THE PT WANTS TO HAVE THE DEVICE REMOVED. TREATING NEUROLOGIST PLANS TO DISCUSS OPTIONS WITH THE PT'S FAMILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCP PULSE GENERATOR PULSE GENERATOR LYJ CYBERONICS, INC. 101 1285

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention MODEL 300-20 NCP BIPOLAR LEAD, EXPIR DATE 2/28/03,| DATE OF MFG 2/15/2001, STERILIZATION LOT NO. 2220.| MEDICATIONS AT TIME OF EVENT ARE UNK.