BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 4541097 · Received February 24, 2015

    Report

    Report Number
    1644487-2015-03958
    Event Type
    Injury
    Date Received
    February 24, 2015
    Date of Event
    January 30, 2015
    Report Date
    January 30, 2015
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S EXPLANTED LEAD AND GENERATOR WERE DISCARDED AFTER SURGERY.

    Description of Event or Problem · 1

    CLINIC NOTES STATE THAT THE PATIENT HAS HAD AN INCREASE IN THE NUMBER OF SEIZURES. IT IS STATED THAT HE HAS HAD A FEW MORE THAN USUAL. PATIENT DOES NOT KNOW WHEN LAST VNS DOSING WAS. THE PATIENT¿S DEPAKOTE DOSE WAS INCREASED. THE PATIENT WAS REFERRED FOR BATTERY CHANGE / POSSIBLE REVISION DUE TO PAINFUL STIMULATION. GOOD FAITH ATTEMPTS FOR FURTHER INFORMATION FROM THE PHYSICIAN HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    FURTHER INFORMATION FROM THE NURSE STATED THAT SHE DID NOT KNOW THE EXACT REASON FOR THE ONSET OF SEIZURES. SHE HAD NO DIAGNOSTICS RESULTS AVAILABLE TO PROVIDE. THE NURSE STATED THAT CLINIC NOTES DATED (B)(6) 2015 STATE THAT THE PATIENT WAS DOSED BUT EXPERIENCED COUGHING DURING TITRATION BUT AGAIN DIAGNOSTICS WERE NOT NOTED. THE NURSE WAS UNABLE TO COMMENT ON THE LOCATION OF THE PAINFUL STIMULATION. THE PATIENT UNDERWENT FULL REVISION ON (B)(6) 2015. PRIOR TO REPLACEMENT THE DEVICE WAS INTERROGATED AND SHOWED THAT THE DEVICE WAS SET TO 0MA. A SYSTEM DIAGNOSTIC TEST WAS RAN BUT WAS INTERRUPTED AS THE PATIENT REACTED TO THE STIMULATION AS IT WAS PAINFUL. IT WAS ALSO REPORTED THAT THE PATIENT THEN WENT INTO SURGERY AND A SYSTEMS DIAGNOSTIC WAS PERFORMED AGAIN AFTER THE PATIENT HAD BEEN SEDATED AND THE PATIENT'S BODY SHOOK WHEN THE DIAGNOSTIC WAS RUN. THE DIAGNOSTIC TEST WAS RUN PRE-OP AND SHOWED DCDC CODE 2 WAS SEEN THERE DIDN'T APPEAR TO BE ANY ISSUES. ATTEMPTS FOR PRODUCT RETURN HAVE BEEN MADE BUT THE PRODUCT HAS NOT BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128519 PULSE GEN MODEL 102R GENERATOR LYJ CYBERONICS, INC. 102R 201757

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention