BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3120083 · Received May 20, 2013

    Report

    Report Number
    1644487-2013-01473
    Event Type
    Injury
    Date Received
    May 20, 2013
    Report Date
    April 24, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2013 STATE THAT THE PATIENT WILL THINK ABOUT A SLEEP STUDY FOR APNEA. ADDITIONALLY, THE NOTES STATE THAT THE VAGUS NERVE STIMULATOR IS BEING UTILIZED AND IS CAUSING A RASPY VOICE. THE PATIENT HAS SOME TROUBLE SWALLOWING, WHERE AS HE DOSES OFF HE FEELS LIKE HE MAY SUFFOCATE. THE VNS REDUCED THE PATIENT'S SEIZURES BY 75 - 100%. FOLLOW UP WITH THE PHYSICIAN'S NURSE FOUND THAT SHE DID NOT BELIEVE THAT THE SLEEP APNEA WAS RELATED TO VNS; HOWEVER, SHE COULD NOT SAY FOR SURE. THE NURSE STATED THAT IT SOUNDED LIKE THE SLEEP STUDY HAD NOT BEEN ORDERED YET, UNLESS IT WAS ORDERED BY SOMEONE ELSE. SHE DID NOT KNOW WHEN THE APNEA WAS FIRST OBSERVED AND COULD NOT PROVIDE ANY ADDITIONAL INFORMATION ON THIS. IN ADDITION, SHE STATED THAT MANY PATIENT'S HAVE RASPY VOICE. NO OTHER INFORMATION WAS PROVIDED ON THE VOICE ALTERATION OR SWALLOWING DIFFICULTIES. THE NURSE STATED THAT THE PHYSICIAN RECENTLY SAW THE PATIENT FOR FOLLOW UP AND THE PHYSICIAN SAID THAT THE PATIENT WAS DOING FINE AND DOESN'T NEED TO BE SEEN AGAIN. ATTEMPTS WERE MADE FOR ADDITIONAL INFORMATION; HOWEVER, THEY WERE UNSUCCESSFUL. NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE PHYSICIAN REPLIED BACK TO A FAX WITH QUESTIONS ABOUT THE EVENTS ON (B)(6) 2013. IT WAS STATED THAT NO CAUSAL OR CONTRIBUTORY PROGRAMMING OR MEDICATION CHANGES PRECEDED THE TROUBLE SWALLOWING AND THE PATIENT DOES NOT HAVE A MEDICAL HISTORY OF SWALLOWING DIFFICULTIES. THE PHYSICIAN DID NOT PROVIDE A CLEAR RESPONSE AS TO WHEN THE EVENTS WERE FIRST OBSERVED OR WHAT THE RELATIONSHIP IS TO VNS. ADDITIONALLY, THE PHYSICIAN STATED THAT SHE DID NOT DIAGNOSE THE SLEEP APNEA. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222216 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 015094

    Patients

    Seq Age Sex Outcome Treatment
    1 Other