BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2210385 · Received August 8, 2011

    Report

    Report Number
    1644487-2011-01798
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 11, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT THE LEAD PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD A PROBLEM WITH HER LEAD AND NEEDED REPLACEMENT. ATTEMPTS FOR ADD'L INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ON (B)(4) 2013 IT WAS REPORTED THAT THE PATIENT HAD A CONSULT WITH THE SURGEON AND THAT HIGH IMPEDANCE WAS OBSERVED. NO FURTHER INFORMATION WAS PROVIDED. DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT THE LEAD PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE.

    Description of Event or Problem · 1

    ON (B)(6) 2013 IT WAS REPORTED THAT THE VNS PATIENT HAS BEEN HAVING PROBLEMS WITH HER LEAD ABOUT 1-1.5 YEARS AGO. THE PATIENT WAS QUESTIONING HAVING IT REMOVED. DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT THE LEAD PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO MENTION TO THE PHYSICIAN THAT THE PATIENT¿S GENERATOR WAS TURNED OFF AFTER THE HIGH IMPEDANCE WAS SEEN. NO X-RAYS WERE TAKEN OR PLANNED AND THERE WAS NOT MENTION TO THE PHYSICIAN OF ANY MANIPULATION OR TRAUMA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT GENERATOR AND LEAD REPLACEMENT ON (B)(6) 2014. THE EXPLANTING FACILITY WILL NOT RETURN EXPLANTED DEVICES FOR ANALYSIS WITHOUT A SUBPOENA; THEREFORE, NO ANALYSIS CAN BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 MUZ CYBERONICS, INC. 302-20 1330

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR