BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3608334 · Received February 5, 2014

    Report

    Report Number
    1644487-2014-00356
    Event Type
    Malfunction
    Date Received
    February 5, 2014
    Date of Event
    January 8, 2014
    Report Date
    January 8, 2014
    Manufacturer
    CYBERONICS
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MANUFACTURER, NO GROSS LEAD DISCONTINUITIES VISUALIZED.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED RECEIVING A HIGH IMPEDANCE WARNING MESSAGE. SYSTEM DIAGNOSTICS WERE COMPLETED WHICH CONFIRMED THE HIGH IMPEDANCE RESULTS. THE PHYSICIAN STATED THAT HE WOULD PROGRAM THE PATIENT'S VNS DEVICE OFF AND REFER THE PATIENT TO THE SURGEON. THE PATIENT HAS BEEN SEEN SEVERAL TIMES SINCE THE LAST BATTERY REPLACEMENT ON (B)(6) 2013, AND EVERYTHING WAS FINE. THE PATIENT WAS SEEN AGAIN ON (B)(6) 2014; HOWEVER, THE HIGH IMPEDANCE WARNING WAS NOT SEEN AGAIN. THE PHYSICIAN INDICATED THAT HE INCREASED THE OUTPUT CURRENT TO 0.25MA AND 0.5 MA, BUT THE PATIENT WAS NOT ABLE TO FEEL THE STIMULATION AT THOSE SETTINGS. THE PHYSICIAN DID NOT RE-PERFORM DIAGNOSTICS. X-RAYS TAKEN DID NOT SHOW ANY BREAK, PER THE PHYSICIAN. THE PHYSICIAN WAS ASKED TO RE-PERFORM DIAGNOSTICS AGAIN, AND THE DIAGNOSTICS AGAIN SHOWED HIGH IMPEDANCE. THE PHYSICIAN DISABLED THE VNS DEVICE AGAIN AND SENT THE X-RAY IMAGES TO THE MANUFACTURER FOR REVIEW. REVIEW OF THE X-RAY IMAGES BY THE MANUFACTURER COULD NOT FIND AN EXACT CAUSE FOR THE HIGH IMPEDANCE. THE GENERATOR WAS SEEN IN THE LEFT CHEST AND THE FILTER FEEDTHRU WIRES WERE INTACT. THE INSERTION OF THE CONNECTOR PIN INSIDE THE CONNECTOR BLOCK CANNOT BE ASSESSED DUE TO THE ANGLE OF THE GENERATOR IN THE X-RAY. THE LEAD WIRE WAS INTACT AT THE LOCATION OF THE CONNECTOR PIN. THERE DID NOT APPEAR TO BE ANY LEAD DISCONTINUITIES OR SHARP ANGLES; HOWEVER, THERE WAS A PORTION OF THE LEAD LOCATED BEHIND THE GENERATOR THAT COULD NOT BE ASSESSED. THE ELECTRODE PLACEMENT APPEARED TO BE NORMAL. THERE APPEARED TO BE A PROPER STRAIN RELIEF BEND AND LOOP, PLACED PER LABELING. THERE WERE TWO TIE DOWNS PRESENT BUT THEY DID NOT APPEAR TO BE PLACED PER LABELING AS A TIE DOWN TO SECURE THE STRAIN RELIEF LOOP WAS NOT PRESENT. REPLACEMENT VNS SURGERY IS LIKELY, BUT HAS NOT OCCURRED TO DATE. ATTEMPTS HAVE BEEN MADE FOR ADDITIONAL INFORMATION; HOWEVER, THEY WERE UNSUCCESSFUL. NO OTHER INFORMATION HAS BEEN PROVIDED ABOUT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74492 LEAD MODEL 302 LEAD MUZ CYBERONICS 302-20 1283

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR