BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 1080590 · Received July 22, 2008

    Report

    Report Number
    1644487-2008-01666
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    April 1, 2008
    Report Date
    July 8, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VNS PT'S MOTHER INDICATED THE PT HAD A LEFT SIDED ABRASION TO THE CHEST, DAYTIME PETIT MAL SEIZURES ARE INCREASING AGAIN, AND THERE IS AN INCREASE IN DROP SEIZURES. IT IS UNK IF THE INCREASE IN SEIZURES ARE ABOVE, BELOW, OR AT PRE VNS BASELINE LEVEL. F/U WITH THE PHYSICIAN REVEALED THAT THE ABRASION WAS DUE TO A SEAT BELT. THE PHYSICIAN INDICATED THERE HAD BEEN NO MENTION OF INCREASE IN SEIZURES. HE STATED DIAGNOSTICS WERE PERFORMED AT THE PT'S LAST ROUTINE OFFICE VISIT. HE DID NOT PROVIDE THE SPECIFIC RESULTS, BUT DID NOT REPORT ANY PROBLEMS. GOOD FAITH ATTEMPTS TO OBTAIN ADD'L INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other