BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3021443 · Received March 26, 2013

    Report

    Report Number
    1644487-2013-00813
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    June 29, 2009
    Report Date
    February 25, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INCORRECT PATIENT IDENTIFIER WAS INADVERTENTLY LISTED ON INITIAL MDR. INCORRECTLY SELECTED PRODUCT PROBLEM INSTEAD OF ADVERSE EVENT ON INITIAL MDR. INCORRECTLY REPORTED AS A MALFUNCTION ON THE INITIAL MDR. ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT ON (B)(6) 2009, THE PATIENT'S MOTHER CALLED THE OFFICE WITH "VNS ISSUES". WHEN ASKED WHAT THESE ISSUES REFERRED TO, THE NURSE STATED THAT, PER THE MOTHER, THE PATIENT'S "SEIZURES WERE NOT THE SAME". IT WAS UNKNOWN WHAT THE EXACT CHANGE IN SEIZURE PATTERN WAS, AS IT WAS NOT REPORTED. THE PATIENT'S MOTHER JUST STATED THAT ONE OF THE SEIZURES LASTED 40 SECONDS. IT IS UNKNOWN IF THIS WAS HOW LONG THE SEIZURES TYPICALLY LASTED OR IF IT WAS LONGER. THE PATIENT WAS ADVISED TO GO TO THE EMERGENCY ROOM; HOWEVER, THE PATIENT DID NOT WANT TO GO. NO DIAGNOSTIC INFORMATION WAS PROVIDED. NO OTHER INTERVENTIONS WERE TAKEN OR PLANNED. PER THE NURSE, IT IS UNKNOWN WHAT THE RELATIONSHIP OF THE CHANGE IN SEIZURE PATTERN WAS TO VNS. NO ADDITIONAL INFORMATION WAS PROVIDED. A REVIEW OF PROGRAMMING HISTORY FOUND DIAGNOSTICS FROM THE DATE OF IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S MOTHER REQUESTED THE DEVICE BE DISABLED ON (B)(6) 2009 FOR PERSONAL REASONS. THE PATIENT'S MOTHER ALSO REQUESTED THAT ALL OF THE PATIENT'S ANTI-EPILEPTIC MEDICATIONS BE STOPPED; HOWEVER, SHE REQUESTED THESE MEDICATIONS AGAIN ON (B)(6) 2009. AS THE PATIENT WAS LAST SEEN BY THIS OFFICE IN (B)(6) 2009, NO ADDITIONAL INFORMATION IS KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122968 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 017152

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR