BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 3132489 · Received May 29, 2013

    Report

    Report Number
    1644487-2013-01612
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 3, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THERE WERE NO UNRESOLVED NON CONFORMANCES FOUND WITH THE GENERATOR PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT PRODUCT ANALYSIS WAS COMPLETED ON THE GENERATOR. AN OPEN CAN MEASUREMENT OF THE BATTERY VOLTAGE DETERMINED THAT THE BATTERY WAS DEPLETED. THE END OF SERVICE CONDITION WAS THE RESULT OF NORMAL, EXPECTED BATTERY DEPLETION BASED ON THE BATTERY LIFE CALCULATION, THE ELECTRICAL TEST RESULTS AND THE BENCH EVALUATION. DURING AN X-RAY REVIEW OF THE GENERATOR DONE PREVIOUSLY DURING ANOTHER INVESTIGATION IT APPEARED AT THAT TIME THAT THE POSITIVE FEED-THRU WIRE MAY HAVE BEEN FRACTURED. THIS MAY HAVE CONTRIBUTED TO THE DETACHMENT OF THE HEADERS. THIS WAS THE PATIENT¿S THIRD GENERATOR WITH FRACTURED FEED-THRU WIRES. THE DEVICE DID NOT MEET THE FUNCTIONAL SPECIFICATIONS DUE TO A DEPLETED BATTERY CONDITION AND THE C10 COMPONENT. AFTER THE C10 COMPONENT WAS BRIDGED WITH A KNOWN GOOD BENCH COMPONENT, THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. ANALYSIS DETERMINED THAT THE C10 COMPONENT DAMAGE OCCURRED IN THE PA LAB DURING THE OPEN-CAN CUTTING PROCESS AND HAD NO IMPACT ON DEVICE PERFORMANCE DURING THE IMPLANT PERIOD.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT DURING REMOVAL OF THE PATIENT¿S GENERATOR DURING A GENERATOR REPLACEMENT THE HEADER DETACHED FROM THE CAN OF THE GENERATOR. THERE WERE NO CLAMPS USED THAT WOULD HAVE CAUSE D THE ISSUE AND WAS UNCLEAR TO THE SURGEON THE CAUSE OF DETACHMENT. PRE-OPERATIVE DIAGNOSTICS WERE WITHIN NORMAL LIMITS. THERE WERE NO X-RAYS TAKEN. THE GENERATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. PRODUCT ANALYSIS IS PLANNED BUT HAS NOT BEEN COMPLETED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THERE WERE NO UNRESOLVED NON CONFORMANCES FOUND WITH THE GENERATOR PRIOR TO DISTRIBUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235949 PULSE GEN MODEL 102R GENERATOR LYJ CYBERONICS, INC. 102R 200637

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR