BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 3140806 · Received May 31, 2013

    Report

    Report Number
    1644487-2013-01648
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    February 13, 2013
    Report Date
    May 6, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BRAND NAME, CORRECTED DATA: PREVIOUSLY SUBMITTED MDR INDICATED THIS INFORMATION WAS UNKNOWN. IT IS NOW KNOWN. THIS REPORT IS BEING SUBMITTED TO CORRECT THIS DATA. MODEL #, SERIAL #, LOT #, EXPIRATION DATE, CORRECTED DATA: PREVIOUSLY SUBMITTED MDR INDICATED THIS INFORMATION WAS UNKNOWN. IT IS NOW KNOWN. THIS REPORT IS BEING SUBMITTED TO CORRECT THIS DATA. IMPLANT DATE, CORRECTED DATA: PREVIOUSLY SUBMITTED MDR INDICATED THE INCORRECT INFORMATION FOR IMPLANT DATE. THIS REPORT IS BEING SUBMITTED TO CORRECT THIS DATA. MANUFACTURE DATE, CORRECTED DATA: PREVIOUSLY SUBMITTED MDR INDICATED THIS INFORMATION WAS UNKNOWN. IT IS NOW KNOWN. THIS REPORT IS BEING SUBMITTED TO CORRECT THIS DATA.

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THE EXPLANTED DEVICE WAS DISCARDED. INFORMATION WAS RETURNED FROM THE PHYSICIAN ON (B)(6) 2013 THAT REPLACEMENT OF THE GENERATOR PRODUCED AN ALMOST IMMEDIATE SIGNIFICANT IMPROVEMENT IN SEIZURE CONTROL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED FOR A BATTERY REPLACEMENT. UPON FOLLOW UP FOR THE REASON OF REPLACEMENT, IT WAS FOUND THAT THE PATIENT EXPERIENCED AN INCREASE IN SEIZURES. PER THE NURSE, IT WAS UNKNOWN IF THE PATIENT'S DEVICE WAS AT END OF SERVICE OR IF THERE WERE ANY OTHER REASONS FOR REPLACING IT BESIDES THE INCREASED SEIZURES. THE NURSE STATED THAT THEY WANTED TO HAVE THE PATIENT'S DEVICE REPLACED IN ORDER TO SEE IF IT WOULD HELP THE PATIENT'S SEIZURES. THE PATIENT WAS SAID TO HAVE A PRIOR HISTORY OF 2-3 SEIZURES PER MONTH, BUT THE LAST REPORT WHEN SEEN ON (B)(6) 2013 INDICATED THE PATIENT WAS EXPERIENCING ABOUT 5 SEIZURES PER WEEK. THE PATIENT HAS NOT BEEN SEEN SINCE SURGERY ON (B)(6) 2013, SO IT IS UNKNOWN IF THE REPLACEMENT HAS MADE A DIFFERENCE. NO DIAGNOSTICS WERE KNOWN, BUT THE PATIENT'S SETTINGS WERE PROVIDED. IT WAS UNKNOWN IF THE PATIENT HAS MULTIPLE SEIZURE TYPES. AS THE PATIENT HAS STAYED ON THE SAME MEDICATION, IT WAS STATED THAT THERE WERE NO KNOWN MEDICATION CHANGES THAT OCCURRED PRIOR TO THE INCREASE IN SEIZURES. NO OTHER INFORMATION WAS PROVIDED. ATTEMPTS HAVE BEEN MADE FOR THE PATIENT'S PRODUCT INFORMATION; HOWEVER, THEY HAVE BEEN UNSUCCESSFUL. IT IS UNKNOWN WHAT THE PATIENT'S GENERATOR MODEL AND SERIAL NUMBER IS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GENERATOR WAS AVAILABLE TO BE RETURNED FOR ANALYSIS. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS, BUT HAS NOT BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    THE EXPLANTED GENERATOR WAS RETURNED ON (B)(6) 2014 AND UNDERWENT ANALYSIS. THE REPORTED ¿END OF SERVICE¿ ALLEGATION WAS CONFIRMED IN THE PA LAB; AN OPEN CAN MEASUREMENT OF THE BATTERY VOLTAGE DETERMINED THAT THE BATTERY WAS DEPLETED. BASED ON THE BENCH ANALYSIS AND THE ELECTRICAL TEST RESULTS, THE DEVICE EXHIBITED CURRENT CONSUMPTION RATES THAT WERE WITHIN SPECIFICATION; THEREBY, DEMONSTRATING NORMAL BATTERY DEPLETION TO AN END OF SERVICE CONDITION. THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THEREFORE, THE ELECTRICAL PERFORMANCE OF THE GENERATOR, AS MEASURED IN THE PA LAB, WILL BE USED TO CONCLUDE THAT NO ABNORMAL PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITION WAS FOUND WITH THE GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242332 PULSE GEN MODEL 102R GENERATOR LYJ CYBERONICS, INC. 102R 200637

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR