BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2935539 · Received January 30, 2013

    Report

    Report Number
    1644487-2013-00237
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    November 28, 2012
    Report Date
    January 4, 2013
    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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS SUSPECTED THE PATIENT'S FALL ON (B)(6) 2012 MAY HAVE CONTRIBUTED TO THE LEAD PIN DISLODGING FROM THE GENERATOR, CAUSING THE HIGH LEAD IMPEDANCE.

    Description of Event or Problem · 1

    REPORTER INDICATED A PATIENT HAD HIGH LEAD IMPEDANCE 10,000 OHMS WITH VNS DIAGNOSTICS TESTING AT AN OFFICE VISIT ON (B)(6) 2013. THE PATIENT WAS ALSO EXPERIENCING INCREASED SEIZURES INCLUDING DROP SEIZURES, WHICH HAVE CAUSED INJURIES. THE PATIENT HAD VNS GENERATOR REPLACEMENT SURGERY PERFORMED EARLIER ON (B)(6) 2012. THE PATIENT EXPERIENCED INCREASED URINATION FOLLOWING THE SURGERY, BUT NO INFECTION WAS NOTED. ON (B)(6) 2012, THE VNS WAS REPORTED TO HAVE BEEN WORKING PROPERLY. ON (B)(6) 2012, THE PATIENT HAD A SEVERE FALL FROM A DROP SEIZURE. X-RAYS WERE PERFORMED WHICH DID NOT IDENTIFY ANY LEAD FRACTURES PER THE REPORTER. THE PATIENT HAD EXPLORATORY SURGERY PERFORMED ON (B)(6) 2013. THE LEAD PIN WAS NOTED TO BE DISCONNECTED FROM THE GENERATOR. AFTER THE LEAD PIN WAS INSERTED, DIAGNOSTICS RESULTED IN APPROXIMATELY 3500 OHMS (NORMAL IMPEDANCE). DIAGNOSTICS WERE REPEATED WITH THE PATIENT IN DIFFERENT POSITIONS AND THE RESULTS WERE ALL WITHIN NORMAL LIMITS. NO NEW DEVICES WERE IMPLANTED. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL AS THE REPORTER DECLINED TO GIVE ANY INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40543 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS INC 103 3402

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention