BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3121764 · Received May 21, 2013

    Report

    Report Number
    1644487-2013-01485
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 25, 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
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE EXPLANTED GENERATOR WAS RETURNED FOR ANALYSIS ON (B)(4) 2013. THE PULSE GENERATOR DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. NO OBSTRUCTIONS WERE OBSERVED IN THE HEADER LEAD CAVITY OR CONNECTOR BLOCKS. A BENCH LEAD INSERTED PAST THE CONNECTOR BLOCKS. IN ADDITION, THE IN-LINE CAVITY GO GAUGE TEST PASSED. IN THE PA 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. DURING THE PRODUCT ANALYSIS THERE WERE NO ANOMALIES FOUND WITH THE PULSE GENERATOR.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT HIGH LEAD IMPEDANCE WAS NOTED WITH VNS DIAGNOSTICS TESTING FOR A NEW PATIENT. THE REPORTER DID NOT HAVE ANY VNS PROGRAMMING OR DIAGNOSTICS HISTORY FOR THE PATIENT AS THE PATIENT WAS NEW. THE VNS WAS DISABLED AND X-RAYS WERE PERFORMED BUT WILL NOT BE SENT TO THE MANUFACTURER FOR REVIEW. IT IS UNKNOWN IF THE PATIENT HAD ANY TRAUMA OR MANIPULATED THE VNS. VNS DIAGNOSTICS HISTORY OBTAINED BY THE MANUFACTURER NOTED NORMAL IMPEDANCE VALUES ON (B)(6) 2007 (DAY OF INITIAL IMPLANT). THE PATIENT LATER HAD GENERATOR REPLACEMENT SURGERY ONLY ON (B)(6) 2013. NORMAL IMPEDANCE WAS OBTAINED WITH THE NEW GENERATOR AND RESIDENT LEAD. AS REINSERTING THE LEAD PIN INTO THE NEW GENERATOR HEADER RESOLVED THE HIGH LEAD IMPEDANCE, THE CAUSE OF THE HIGH LEAD IMPEDANCE IS LIKELY DUE TO THE PIN BEING INSERTED JUST ENOUGH TO PROVIDE INTERMITTENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225097 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS INC 102 016318

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR