BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2465251 · Received February 21, 2012

    Report

    Report Number
    1644487-2012-00461
    Event Type
    Injury
    Date Received
    February 21, 2012
    Date of Event
    August 29, 2011
    Report Date
    January 26, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF BIRTH, CORRECTED DATA: THE INITIAL REPORT INADVERTENTLY REPORTED THE DATE INCORRECTLY. DATE RECEIVED BY MANUFACTURER, CORRECTED DATA: THE SUPPLEMENTAL REPORT #7 INADVERTENTLY REPORTED THE DATE INCORRECTLY. IT SHOULD HAVE REPORTED THE DATE AS 10/24/2014.

    Additional Manufacturer Narrative · 1

    THE SUPPLEMENTAL REPORT #1 INADVERTENTLY DID NOT INCLUDE THAT THE PATIENT NOW REPORTEDLY HAS SEVEN BLOOD CLOTS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE EPILEPTOLOGIST'S OFFICE WHICH REVEALED THAT THEY ARE UNABLE TO PROVIDE AN ASSESSMENT REGARDING THE RELATIONSHIP OF THE PATIENT'S HEART CONDITIONS TO VNS. IT WAS NOTED THAT THE PATIENT'S VNS SYSTEM HAS BEEN WORKING PROPERLY AND NO CHANGES HAVE BEEN MADE TO THE PATIENT'S MEDICATION OR THE VNS SETTINGS. THEY ARE UNAWARE IF ANY INTERVENTIONS HAVE BEEN PLANNED OR IF THE PATIENT HAD A MEDICAL HISTORY OF BLOOD CLOTS OR HEART PROBLEMS. THE SURGEON'S OFFICE REPORTED THAT THE PATIENT'S BLOOD CLOTS, SWELLING AND HEART VALVE PROBLEMS ARE NOT RELATED TO VNS. THE PATIENT HAS BEEN REFERRED TO A VASCULAR SPECIALIST REGARDING THESE EVENTS. NO CAUSAL OR CONTRIBUTORY MEDICATION CHANGES PRECEDE THE ONSET OF THESE EVENTS, AND THE PATIENT DOES NOT HAVE A MEDICAL HISTORY OF THESE EVENTS. PATIENT MANIPULATION OR TRAUMA MAY HAVE OCCURRED TO HAVE CAUSED/CONTRIBUTED TO THE SWELLING. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE SURGEON. THE PATIENT FURTHER REPORTED THAT HE HAS SEVEN BLOOD CLOTS, AND HAS SWELLING IN HIS LEGS AND LEFT ARM, WHICH HE DIDN'T HAVE BEFORE VNS. THE PATIENT SAYS THAT WITH VNS, HE IS HAVING MORE HEALTH PROBLEMS THAN WHAT HE WANTS. ATTEMPTS FOR ADDITIONAL INFORMATION FROM THE SURGEON HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VNS PT HAD SWELLING IN HIS ARMS AND LEGS AROUND THE TIME OF VNS IMPLANT ON (B)(6) 2011 THROUGH (B)(6) 2011. THE PT WENT TO THE ER IN (B)(6) 2011, AND THE PHYSICIANS FOUND THAT HE HAD A BLOOD CLOT IN HIS ARM AND ONE IN HIS LEG. HE WAS HOSPITALIZED AT THAT TIME. DURING THIS HOSPITALIZATION, THE PT WAS DIAGNOSED WITH ONE OF HIS HEART VALVES NOT OPENING. THE PT INDICATED THAT HE THINKS THESE EVENTS ARE ALL RELATED TO VNS. THE PT HAS REPORTEDLY NOT HAD HIS VNS CHECKED IN A WHILE AND PROBABLY WILL NOT UNTIL THE BLOOD CLOTS AND HEART VALVE PROBLEM RESOLVE. ATTEMPTS FOR ADD'L INFO FROM THE PHYSICIAN HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM THE NEUROLOGIST¿S OFFICE THAT IN CLINIC NOTES DATED (B)(6) 2012, IT WAS DOCUMENTED THAT THE DEVICE WAS OFF. THE NURSE WAS UNABLE TO FIND WHEN IT WAS FIRST TURNED OFF. AN ADDITIONAL ATTEMPT FOR INFORMATION HAS BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THE GENERATOR AND LEAD EXPLANTED ON (B)(6) 2014. THE EXPLANTED PRODUCTS HAVE NOT BEEN RECEIVED BY THE MANUFACTURER TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON WHO REPORTED THAT THE PATIENT'S REPORTED ADDITIONAL HEALTH PROBLEMS ARE NOT RELATED TO VNS. THE PATIENT HAS BEEN REFERRED TO A VASCULAR SPECIALIST, BUT THE PATIENT HAS NOT FOLLOWED UP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS SEVEN BLOOD CLOTS AND HAS SWELLING IN THE LEGS AND LEFT ARM, AND THE PATIENT DID NOT HAVE THESE BLOOD CLOTS AND SWELLING PRIOR TO VNS. ATTEMPTS FOR ADDITIONAL INFORMATION FROM THE SURGEON'S OFFICE HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE PATIENT WANTS TO THE VNS DEVICE EXPLANTED BECAUSE IT CAUSED HIM TO HAVE BLOOD CLOTS. THE PATIENT INDICATED THAT HE HAS HAD THE DEVICE DISABLED 'FOR A PERIOD OF TIME.' THE PATIENT IS REPORTEDLY NOW ON COUMADIN, AND CONTINUES TO REPORT THAT HIS HEALTH HAS DECLINED WITH VNS. HE PLANS ON REDUCING COUMADIN IN ANTICIPATION OF VNS EXPLANT. ATTEMPTS FOR ADDITIONAL INFORMATION ON THE DEVICE DISABLEMENT HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE EXPLANT HOSPITAL THAT THE EXPLANTED PRODUCTS WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 2701

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization