BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 3083371 · Received April 29, 2013

    Report

    Report Number
    1644487-2013-01196
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 3, 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
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED AND AN ANALYSIS OF PROGRAMMING HISTORY WAS PERFORMED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THE DEVICE MET ALL FINAL TESTING SPECIFICATIONS PRIOR TO DISTRIBUTION. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THE PATIENT HAD HIGH LEAD IMPEDANCE DURING THE OFFICE VISIT. THE PHYSICIAN HAD ORDERED A CHEST X-RAY PRIOR TO THIS VISIT DUE TO "SWELLING" ON THE LEFT SIDE OF THE NECK, BUT THIS CHEST X-RAY WAS NON-CONCLUSIVE AND FOUND NO VISUAL LEAD BREAK PER THE PHYSICIAN. THE X-RAYS WILL NOT BE SENT TO THE MANUFACTURER FOR REVIEW. REVIEW OF THE DEVICE MANUFACTURER'S RECORDS FOR THE LEAD CONFIRMED THE LEAD MET ALL FINAL TESTING SPECIFICATIONS PRIOR TO DISTRIBUTION. FOLLOW UP WITH THE PHYSICIAN CONFIRMED THAT THE HIGH IMPEDANCE WAS FIRST OBSERVED DURING THE OFFICE VISIT OF (B)(6) 2013. THE PHYSICIAN STATED THAT SHE SUPPOSED PATIENT MANIPULATION OR TRAUMA COULD HAVE CAUSED OR CONTRIBUTED TO THE HIGH IMPEDANCE; HOWEVER, SHE WAS NOT SURE. NO DIAGNOSTIC INFORMATION WAS PROVIDED. IN REGARDS TO THE SWELLING, THE PHYSICIAN STATED THAT SHE DID NOT KNOW IF THERE WAS A RELATIONSHIP TO VNS AND NO INTERVENTIONS WERE TAKEN OR PLANNED. ADDITIONAL FOLLOW UP FOUND THAT THE PATIENT HAD FALLEN ON HIS NECK ON AN UNKNOWN DATE. AN MRI COULD NOT BE PERFORMED DUE TO MRI PRECAUTIONS; HOWEVER, A CT SCAN IS PLANNED TO SEE IF THERE IS ANY INJURY TO THE NECK. IT IS UNKNOWN IF THERE IS A RELATIONSHIP BETWEEN THE FALL AND THE SWELLING. THE PATIENT MIGHT BE REFERRED TO SEE A SURGEON FOR POSSIBLE EXPLORATORY SURGERY; HOWEVER, NO SURGERY HAS BEEN SCHEDULED YET. NO ADDITIONAL INFORMATION WAS PROVIDED. A PROGRAMMING HISTORY REVIEW WAS PERFORMED WHICH FOUND THE PATIENT'S LAST SETTINGS FROM (B)(6) 2012 AND DIAGNOSTIC DATA FROM THE DATE OF IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185013 BIPOL LEAD MODEL 300 LEAD LYJ CYBERONICS INC 300-20 976

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other