BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 2873444 · Received December 14, 2012

    Report

    Report Number
    1644487-2012-03334
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    September 9, 2012
    Report Date
    November 15, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE, CORRECTED DATA: PREVIOUSLY SUBMITTED MDR INDICATED AN INCORRECT EVENT DATE. THIS REPORT IS BEING SUBMITTED TO CORRECT THIS FIELD.

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    DIAGNOSTICS PERFORMED ON THE DAY OF SURGERY, (B)(6)2012, SHOWED THAT THE DEVICE WAS NOT AT END OF SERVICE. THE GENERATOR WAS REPLACED FOR PROPHYLACTIC REASONS. IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT THE DEVICE WOULD BE RETURNED TO THE COMPANY AFTER GOING THROUGH PATHOLOGY; HOWEVER, THE PRODUCT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    THE PATIENT'S EXPLANTED GENERATOR WAS RETURNED ON (B)(6) 2013 AND IS PENDING PRODUCT ANALYSIS.

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE PHYSICIAN REPORTED THAT THE PATIENT WAS REFERRED FOR A GENERATOR REPLACEMENT. CLINIC NOTES DATED (B)(6) 2012 WERE LATER RECEIVED WHICH STATE THAT THE PATIENT HAD A CLINICALLY SIGNIFICANT INCREASE IN SEIZURES OVER THE PAST TWO MONTHS. IT WAS STATED THAT THE PATIENT HAD THE VNS FOR SOME TIME AND ON INITIAL IMPLANTATION THE DEVICE HAD MADE A SIGNIFICANT IMPACT UPON THE PATIENT'S SEIZURE FREQUENCY. PER THE NOTES, THE PATIENT REPORTED THAT THE DEVICE HAD NOT BEEN INTERROGATED FOR SEVERAL YEARS AND THERE WAS CONCERN IF IT WAS OPERATING PROPERLY. THE DEVICE WAS INTERROGATED AND DIAGNOSTICS FOUND THAT IT WAS NOT AT END OF SERVICE. PER THE NOTES, THE PHYSICIAN STATED IT WAS LIKELY THE BATTERY WAS DEPLETED DESPITE THE DIAGNOSTICS DUE TO THE NUMBER OF HOURS THE DEVICE WAS ON, THE TOTAL OPERATING HOURS, AND THE IMPLANT DATE. IT WAS FURTHER STATED THAT THE PATIENT WAS REFERRED FOR BATTERY REPLACEMENT PROPHYLACTICALLY AS HE WAS EXPERIENCING A CLINICALLY SIGNIFICANT INCREASE IN SEIZURES OVER THE LAST TWO MONTHS. NO ADDITIONAL INFORMATION WAS PROVIDED. PER HOSPITAL POLICY, NO INFORMATION WILL BE RELEASED.

    Description of Event or Problem · 1

    PRODUCT ANALYSIS WAS PERFORMED ON THE EXPLANTED GENERATOR TO TEST FOR PROPER FUNCTIONALITY OF THE PULSE GENERATOR IN ITS ABILITY TO PROVIDE APPROPRIATE PROGRAMMED OUTPUT CURRENTS. IN THE PRODUCT ANALYSIS LAB, THE DEVICE OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24-HRS, WHILE THE GENERATOR WAS PLACED IN A SIMULATED BODY TEMPERATURE ENVIRONMENT. RESULTS SHOWED NO SIGNS OF VARIATION IN THE PULSE GENERATOR'S OUTPUT SIGNAL AND DEMONSTRATED THAT THE DEVICE PROVIDED THE EXPECTED LEVEL OF OUTPUT CURRENT FOR THE ENTIRE MONITORING PERIOD. THE PULSE GENERATOR DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. THE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS AS DEFINED IN FINAL ELECTRICAL TEST. DURING THE PRODUCT ANALYSIS THERE WERE NO ANOMALIES FOUND WITH THE PULSE GENERATOR. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102R GENERATOR LYJ CYBERONICS, INC. 102R 009157

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention