BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 2880504 · Received December 19, 2012

    Report

    Report Number
    1644487-2012-03373
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    June 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2012 FOUND THAT THE PATIENT WAS HAVING ABOUT FOUR TO SEVEN SEIZURES PER WEEK. WHEN THE PATIENT'S DEVICE WAS CHECKED SHE STATED THAT IT WAS SHOCKING HER. PER THE NOTES, THE PHYSICIAN STATES THAT IT IS TIME FOR A BATTERY REPLACEMENT; HOWEVER THE PATIENT IS UNSURE IF SHE WANTS THE DEVICE REPLACED AS SHE IS 'DOING ABOUT THE SAME.' FOLLOW UP WITH THE PHYSICIAN FOUND THAT THE PATIENT IS BEING REFERRED FOR A PROPHYLACTIC REPLACEMENT SOLELY BASED ON THE LENGTH OF TIME THE DEVICE HAS BEEN IMPLANTED. THE PATIENT COMPLAINS THAT THE SEIZURES HAVE WORSENED OVER THE LAST FIVE MONTHS AND THAT SHE GETS SHOCKED INTERMITTENTLY EVERY ONCE A WEEK FOR THE PAST THREE WEEKS. NO MEDICATION OR KNOWN STRESS RELATED ISSUES PRECEDED EITHER THE INCREASE IN SEIZURES OR THE SHOCKING SENSATION. IN ADDITION, NO CONTRIBUTING PROGRAMMING CHANGES OCCURED PRIOR TO THE EVENTS EITHER.

    Description of Event or Problem · 1

    FOLLOW UP WITH THE PHYSICIAN FOUND THAT THE PATIENT HAS NOT REPORTED ANY INCREASE IN SEIZURES TO THEM AND WHEN THE PATIENT WAS LAST SEEN ON (B)(6) 2012 THE PATIENT STATED THAT SHE WAS HAVING 4-7 SEIZURES A WEEK. NO OTHER INFORMATION WAS AVAILABLE ON THE PATIENT'S SEIZURES. THE NURSE STATED THAT THE PATIENT HAS NOT CALLED SINCE THAT VISIT TO REPORT ANY PROBLEMS OR CHANGES IN SEIZURES. IN ADDITION, THE NURSE WAS UNAWARE OF THE "SHOCKING" SENSATION THE PATIENT EXPERIENCED AS THE PATIENT HAS NOT REPORTED ANYTHING SINCE THAT LAST NOVEMBER VISIT. THE PATIENT'S PRE-VNS SEIZURE LEVEL WAS UNKNOWN TO GIVE A COMPARISON. IN ADDITION, IT WAS STATED THAT THE PATIENT DOES NOT SWIPE HER MAGNET WHEN GETTING SEIZURES AND IS NON-COMPLAINT. IT WAS ALSO STATED THAT THE OFFICE CALLED THE PATIENT ON (B)(6) 2013 TO TELL HER THAT SHE NEEDED HER DEVICE REPLACED AND THE PATIENT DID NOT REPORT ANY INCREASE IN SEIZURES. THE PATIENT HAS BEEN TOLD REPEATEDLY THAT THE DEVICE NEEDS TO BE REPLACED PROPHYLACTICALLY; HOWEVER, THE PATIENT IS NON-COMPLAINT PER THE NURSE.

    Description of Event or Problem · 1

    SINCE THE LAST REPORT THE PHYSICIAN'S OFFICE RECEIVED FROM THE PATIENT INDICATED THAT THE PATIENT DID NOT HAVE ANY ADDITIONAL SEIZURES AND WAS NOT COMPLIANT WITH THE REQUEST FROM THE PHYSICIAN TO REPLACE THE GENERATOR PROPHYLACTICALLY AT THAT TIME, THE EVENTS OF THIS REPORT CONCLUDED AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102R GENERATOR LYJ CYBERONICS, INC. 102R 010464

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other