BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 2973416 · Received February 21, 2013

    Report

    Report Number
    1644487-2013-00479
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 1, 2010
    Report Date
    January 22, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    DATE OF EVENT, CORRECTED DATA: AS ONLY THE YEAR OF THE EVENT IS KNOWN, THE EVENT DATE HAS BEEN UPDATED FROM THE DATE LISTED ON THE INITIAL MDR.

    Description of Event or Problem · 1

    IN A CALL WITH THE PHYSICIAN'S NURSE, IT WAS REPORTED THAT THE PATIENT HAD 13 SEIZURES IN 2009, 10 IN 2009, 41 IN 2010, AND 3 IN 2012 PRIOR TO AUGUST. WHEN ASKED IF THE 41 SEIZURES REPRESENTED AN INCREASE IN SEIZURES, THE NURSE STATED THAT SHE DID NOT KNOW AS ONLY THE NUMBER OF SEIZURES WAS LISTED AND NOT THE RELATIONSHIP. IN ADDITION, IT WAS UNKNOWN WHAT THE RELATIONSHIP OF THE SEIZURES WAS TO PRE-VNS LEVELS AS THE NURSE COULD NOT REMEMBER THE PRE-VNS LEVELS. PER THE NURSE, THE PATIENT LIKELY HAD LESS SEIZURES, AS THE PATIENT ALWAYS REPORTED THAT SHE HAD NO SEIZURES OR JUST ONE OR TWO WHENEVER SHE CAME IN FOR AN OFFICE VISIT. THE NURSE LOOKED THROUGH RECORDS FROM THE AGENCY AND PER THE NOTES, THE PATIENT HAD 1 GRAND MAL AND 12 PETITE MAL SEIZURES IN 2008, 0 GRAND MAL AND 23 PETITE MAL SEIZURES IN 2009, AND 16 GRAND MAL AND 162 PETITE MAL SEIZURES IN 2010. THE NURSE STATED THAT THE HIGH NUMBER FROM THE AGENCY WERE LIKELY INACCURATE AS THE AGENCY WAS NOT ALWAYS ABLE TO DISTINGUISH SEIZURE ACTIVITY. SHE EXPLAINED THAT OFTEN THE AGENCY WOULD SOMETIMES DESCRIBE A SIMPLE ARM MOTION AS A PETITE MAL SEIZURE, AND THEREFORE THERE WAS A DISCREPANCY IN IDENTIFYING THIS SEIZURE TYPE. THE NURSE STATED THAT THE PHYSICIAN MOST LIKELY TOOK THIS DISCREPANCY INTO ACCOUNT, WHICH IS WHY HE HAD A MUCH LOWER SEIZURE COUNT PER YEAR. THE RELATIONSHIP BETWEEN THE SEIZURES AND VNS THERAPY WAS UNKNOWN. NO OTHER INFORMATION WAS PROVIDED. ATTEMPTS WERE MADE TO GET THE PATIENT'S DEVICE INFORMATION; HOWEVER, THEY WERE UNSUCCESSFUL. PER THE IMPLANTING HOSPITAL, THE DEVICE MODEL AND SERIAL NUMBERS WERE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77025 PULSE GEN MODEL UNK GENERATOR LYJ CYBERONICS, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR