BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2944417 · Received February 5, 2013

    Report

    Report Number
    1644487-2013-00293
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    November 23, 2012
    Report Date
    January 8, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2013 WHEN THE SURGEON REPORTED THAT A NON-ABSORBABLE SUTURE WAS USED TO TIE-DOWN THE GENERATOR AND LEAD TO THE FASCIA DURING IMPLANT. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE.

    Description of Event or Problem · 1

    AN IMPLANT CARD WAS RECEIVED INDICATING THAT THE PATIENT UNDERWENT GENERATOR AND LEAD REPLACEMENT ON (B)(6) 2013. THE EXPLANTING FACILITY REPORTED THAT THE EXPLANTED DEVICES WERE DISCARDED DURING THE SURGERY AND WILL NOT BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PHYSICIAN THAT THE PATIENT WAS IN THE OFFICE ON (B)(6) 2012 STATING SHE NOTICED THE WIRE IN HER NECK HAD MOVED AND SUBSEQUENTLY SHE STARTED TO EXPERIENCE HOARSENESS THAT WAS CONSTANT AND HAVING SOME COUGHING. THE PATIENT DENIED ANY TRAUMA OR FALLS. PER THE PHYSICIAN, DIAGNOSTICS WERE PERFORMED AND WERE WITHIN NORMAL LIMITS. THE PHYSICIAN INDICATED THAT IT DOES APPEAR THAT THE WIRE HAS MOVED SOME AND HE STATES THAT HE HAS SENT THE PATIENT FOR AN X-RAY. THE DEVICE WAS DISABLED AND PATIENT'S HOARSENESS STOPPED IMMEDIATELY. HE STATES THAT PATIENT HAS NOT HAD ANY SEIZURE EVENT SINCE HE HAS BEEN HER PHYSICIAN. ADDITIONAL INFORMATION WAS THEN RECEIVED FROM THE PATIENT'S CAREGIVER, WHO STATES THAT HIS WIFE'S WIRE HAS MOVED AND BEGAN TO CAUSE HER DISCOMFORT WITH DIFFICULTY SWALLOWING AND EATING. HE STATED THAT AFTER THE DEVICE WAS DISABLED, THE PATIENT STARTED TO HAVE SEIZURES AGAIN (BELOW BASELINE) WHEN SHE HAD BEEN SEIZURE FREE. PER THE CAREGIVER, HE DID NOT THINK THAT ANY TRAUMA HAD OCCURRED BUT HE STATED THAT SHE DOES HYPEREXTEND HER NECK IN SOME INTIMATE MOMENTS. FOLLOW UP WAS PERFORMED AND IT WAS INDICATED THAT THE MIGRATION, PAIN, VOICE ALTERATIONS, COUGHING, AND DYSPHAGIA (FEELING LIKE NECK WAS SWOLLEN) WERE ALL FIRST NOTED ON (B)(6) 2012. THE INCREASED SEIZURES WAS NOTED ON (B)(6) 2012 WHICH WAS ATTRIBUTED TO THE DEVICE BEING DISABLED. THE PATIENT DOES NOT HAVE A MEDICAL HISTORY OF DYSPHAGIA PRE-VNS. A REVIEW OF AVAILABLE PROGRAMMING HISTORY WAS PERFORMED AND THE LAST DIAGNOSTICS FROM (B)(6) 2012 HAD RESULTS WITHIN NORMAL LIMITS. ON (B)(6) 2013 INFORMATION WAS OBTAINED INDICATING THAT THE PATIENT WAS REFERRED TO A SURGEON FOR POSSIBLE REVISION SURGERY. SURGERY HAS NOT OCCURRED TO DATE, AND ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47695 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 201292

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention