BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1972404 · Received January 24, 2011

    Report

    Report Number
    1644487-2011-00107
    Event Type
    Injury
    Date Received
    January 24, 2011
    Date of Event
    September 1, 2010
    Report Date
    December 29, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH CLINIC NOTES DATED (B)(6) 2010, THAT A VNS PT EXPERIENCED A RECENT BREAK THROUGH IN SEIZURES. THE PT HAD TWO SEIZURES IN ONE DAY THAT WERE PARTIAL IN NATURE AND TRANSITIONED TO GRAND MAL SEIZURES. MOREOVER, THE TREATING PHYSICIAN INDICATED THAT THE PATIENT'S ANTI-EPILEPTIC DRUG LEVELS WERE LOWER THAN THE PAST. THE PT'S VNS WAS INTERROGATED AT THE OFFICE VISIT AND SETTINGS WERE UNCHANGED. INTERVENTIONS TAKEN ACCORDING TO THE NOTES WERE TO INCREASE THE PATIENT'S MEDICATIONS. REVIEW OF THE MFR'S PROGRAMMING DATABASE INDICATED THAT THE LAST KNOWN DIAGNOSTICS WERE FROM (B)(6) 2009 AND WERE WITHIN NORMAL LIMITS (OK/OK/0/NO). ADD'L INFO WAS RECEIVED FROM THE OFFICE OF THE TREATING NEUROLOGIST INDICATING THAT THE CAUSE OF THE SEIZURES WAS UNK. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 009121

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention