BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2191587 · Received July 20, 2011

    Report

    Report Number
    1644487-2011-01628
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 22, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INADVERTENTLY LISTED WRONG PRODUCT INFORMATION.

    Description of Event or Problem · 1

    ON (B)(6), 2011, A VNS TREATING PHYSICIAN REPORTED THAT THE VNS PT WAS EXPERIENCING AN INCREASE IN SEIZURES OVER THE PAST MONTH, BELOW PRE-VNS BASELINE LEVELS. NO CAUSAL OR CONTRIBUTORY PROGRAMMING CHANGES, MEDICATION CHANGES, OR OTHER EXTERNAL FACTORS PRECEDING THE ONSET OF THE INCREASE IN SEIZURES. THE PHYSICIAN REPORTED THAT HE IS WORRIED THAT THE DEVICE MAY HAVE MALFUNCTIONED CAUSING THE INCREASE IN SEIZURES. DETAILS REGARDING THE MALFUNCTION WERE NOT PROVIDED. GOOD FAITH ATTEMPTS FOR PROD INFO FROM THE IMPLANTING HOSP HAVE BEEN TO NO AVAIL THUS FAR. ALSO, GOOD FAITH ATTEMPTS TO THE PHYSICIAN FOR CLARIFICATION REGARDING THE DEVICE MALF HAVE BEEN FRUITLESS. IF FURTHER INFO IS RECEIVED, IT WILL BE REPORTED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, ADDITIONAL INFORMATION WAS RECEIVED WHEN IT WAS DISCOVERED THAT THE VNS PATIENT IS SCHEDULED FOR BATTERY REPLACEMENT IN (B)(6) 2011.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE IMPLANTING HOSPITAL REPORTED THAT THE PATIENT IS IMPLANTED WITH A MODEL 102R GENERATOR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2011, WHEN IT WAS DISCOVERED THAT THE VNS PATIENT WAS HAVING PROPHYLACTIC BATTERY REPLACEMENT SURGERY THAT DAY. THE EXPLANTED GENERATOR WAS REPORTED TO BE DISCARDED BY THE HOSPITAL AFTER THE SURGERY. A BATTERY LIFE CALCULATION WAS PERFORMED ON (B)(6) 2011, WHICH REVEALED NEGATIVE YEARS UNTIL ERI=YES. ON (B)(6) 2011, THE CASE MANAGER REPORTED THAT THE VNS PATIENT HAD ACTUALLY NOT GONE FOR PROPHYLACTIC BATTERY REPLACEMENT ON (B)(6) 2011. THE GROUP HOME THE PATIENT LIVES IN WAS REPORTED TO BE DRAGGING THEIR FEET AND THE PATIENT'S MOTHER WAS OUT OF TOWN SO THE SURGERY WAS CANCELLED AND WILL TAKE PLACE AT ANOTHER TIME. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT YET OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 016318

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR