BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 4922247 · Received July 17, 2015

    Report

    Report Number
    1644487-2015-05201
    Event Type
    Malfunction
    Date Received
    July 17, 2015
    Date of Event
    June 23, 2015
    Report Date
    June 23, 2015
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION WAS INCORRECTLY REPORTED ON THE INITIAL MFR. REPORT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    LEAD REVISION SURGERY TOOK PLACE ON (B)(6) 2015 DUE TO THE HIGH IMPEDANCE FOUND. IT WAS NOTED THAT THE LEAD APPEARED TO HAVE A CLEAN CUT DURING THE SURGERY, WHICH WOULD LIKELY HAVE CONTRIBUTED TO THE HIGH IMPEDANCE FOUND. IT IS UNKNOWN HOW OR WHEN THE LEAD FIRST BECAME SEVERED. ONCE THE LEAD WAS REPLACED, SYSTEM DIAGNOSTICS WERE RUN AGAIN AND WERE WITHIN ACCEPTABLE LIMITS. IT WAS REPORTED THAT THE LEAD WAS DISCARDED AT THE HOSPITAL AND WILL NOT BE RETURNED FOR ANALYSIS. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    FOLLOWING GENERATOR REPLACEMENT SURGERY FOR NORMAL END OF SERVICE, HIGH IMPEDANCE WAS OBSERVED. IT WAS REPORTED THAT DEVICE DIAGNOSTICS WERE UNABLE TO BE RUN PRIOR TO THE SURGERY BECAUSE THE GENERATOR BATTERY WAS COMPLETELY DEPLETED. THE SURGEON INDICATED THAT HE WANTED THE DEVICE PROGRAMMED ON AND TO FOLLOW-UP WITH THE PATIENT IN 3 WEEKS. NO KNOWN SURGICAL INTERVENTIONS HAVE OCCURRED TO DATE TO CORRECT THE HIGH IMPEDANCE. NO ADDITIONAL RELEVANT INFORMATION HAD BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467165 LEAD MODEL 302 LEAD MUZ CYBERONICS, INC. 302-20 1354

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR