BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 3182075 · Received June 21, 2013

    Report

    Report Number
    1644487-2013-01877
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 21, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE RECEIVED BY MANUFACTURER (MO/DAY/YR): INCORRECT AWARE DATE LISTED ON INITIAL MDR. CORRECT INITIAL AWARE DATE WAS (B)(6) 2013.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    FOLLOW UP FOUND THAT THE PATIENT WILL NOT BE PURSUING VNS REPLACEMENT SURGERY, AS THE PATIENT HAS BEEN ADMITTED FOR BILATERAL, NON-OPERABLE MASSES IN BOTH BREASTS AND COLON AND HAS AN ANTICIPATED SIX MONTHS LEFT TO LIVE. THE PHYSICIAN IS IN AGREEMENT WITH THE DECISION NOT TO PURSUE SURGERY AND STATED THAT THE CANCER IS NOT RELATED TO VNS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT SHE WAS IN THE EMERGENCY ROOM THE NIGHT OF (B)(6) 2013 FOR A SEIZURE, BUT SHE WAS NOT SURE IF IT WAS A SEIZURE. SHE STATED THAT SHE HAD BEEN FULLY CONSCIOUS, BUT "COULD NOT CONTROL HER BODY." THIS SENSATION WAS DESCRIBED AS UNCONTROLLABLE JERKING. IT WAS ADDITIONALLY REPORTED BY THE PHYSICIAN THAT THE PATIENT WAS QUICKLY "COMING TO EOS"; HOWEVER, AS THE PATIENT DOES NOT HAVE INSURANCE, SHE IS SEARCHING FOR ALTERNATIVE WAYS TO PAY FOR A REPLACEMENT. ON (B)(6) 2013, THE PATIENT REPORTED THAT SHE HAD AN "IRRITATED SPOT" AT THE GENERATOR SITE. SHE SAW A PHYSICIAN IN THE EMERGENCY ROOM FOR THIS ON (B)(6) 2013 WHO SUGGESTED AN ANTIBIOTIC CREAM. PER THE PATIENT, THE PHYSICIAN INCREASED HER MEDICATION DOSAGE ON (B)(6) 2013. HOWEVER, AS OF (B)(6) 2013 THE PATIENT HAD NOT YET INCREASED THE DOSAGE AS SHE WAS WAITING ON THE MEDICATION TO BE DELIVERED FROM HER PHARMACEUTICAL SUPPLIER. FOLLOW UP WITH THE PHYSICIAN FOUND THAT THE PATIENT'S EXPERIENCE OF NOT BEING ABLE TO CONTROL HER BODY WAS NOT CONSIDERED A CHANGE IN SEIZURE TYPE, BUT AN INCREASED FREQUENCY OF SEIZURES. THIS INCREASED SEIZURE FREQUENCY WAS FIRST OBSERVED ON (B)(6) 2013 AND IS ATTRIBUTED TO THE VNS DEVICE BEING NEAR END OF SERVICE PER INTERROGATION. THE PATIENT'S SETTINGS WERE PROVIDED, BUT DIAGNOSTICS WERE NOT. INTERVENTIONS INCLUDED INCREASING THE PATIENT'S MEDICATIONS AND WORKING TO GET THE PATIENT ON A DONATION PROGRAM FOR A VNS REPLACEMENT. THE PHYSICIAN STATED THAT SHE WAS NOT AWARE OF THE IRRITATED SPOT, AND THEREFORE HAD NO INFORMATION TO PROVIDE ON THIS EVENT. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282239 PULSE GEN MODEL 101 GENERATOR LYJ CYBERONICS, INC. 101 38176C

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other