BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 2900553 · Received January 7, 2013

    Report

    Report Number
    1644487-2013-00084
    Event Type
    Injury
    Date Received
    January 7, 2013
    Date of Event
    September 1, 2012
    Report Date
    December 12, 2012
    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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2012 WERE RECEIVED FOR THE PATIENT'S REFERRAL FOR GENERATOR REPLACEMENT WHICH INDICATED THAT THE PATENT'S SEIZURE LOG FROM (B)(6) 2012 DESCRIBES THAT THE PATIENT CONTINUES TO HAVE DAILY SPELLS AT SCHOOL THAT INVOLVE DECREASED AWARENESS AND AFTERWARDS WILL SOMETIMES COMPLAINT OF BEING UNABLE TO MOVE HIS LEGS. THE CAREGIVER HAD CONCERNS THAT SOME OF HIS SPELLS COULD BE RELATED TO SIDE EFFECTS FROM ANTISEIZURE MEDICATIONS. SPELLS OF RIGIDITY AND DECREASED RESPONSIVENESS DID SEEM TO IMPROVE AFTER PLACEMENT OF VNS IN 2008 BUT HAVE DRAMATICALLY INCREASED SINCE (B)(6) 2012, NOW OCCURRING MULTIPLE TIMES PER DAY. UPON INTERROGATION OF HIS VNS GENERATOR, THE BATTERY WAS REPORTED TO BE LOW. THE PHYSICIAN RECOMMENDED KEEPING THE SAME ANTI-EPILEPTIC MEDICATION REGIMEN. ATTEMPTS FOR ADDITIONAL INFORMATION FROM THE PHYSICIAN AND MEDICAL RECORDS FOR PRODUCT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. THE PATIENT HAD GENERATOR REPLACEMENT SURGERY ON (B)(6) 2012. ATTEMPTS FOR PRODUCT RETURN HAVE BEEN UNSUCCESSFUL AS THE REPRESENTATIVE AT THE HOSPITAL INDICATED THAT THE DEVICE WAS NOT RECEIVED FOLLOWING EXPLANT. THE DEVICE IS NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    OF NOTE, IN THE CLINIC NOTES DATED (B)(6) 2012 THE PHYSICIAN WAS SUSPICIOUS THAT THE SPELLS OF DECREASED RESPONSIVENESS REFLECT NON-EPILEPTIFORM SPELLS. A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. HOWEVER, THE NEAR-END-OF-SERVICE (NEOS) INDICATOR WAS SET TO YES. THE BATTERY WAS PARTIALLY DEPLETED AND DETERMINED TO BE THE RESULT OF NORMAL EXPECTED BATTERY CONSUMPTION BASED ON THE BATTERY LIFE ANALYSIS AND ELECTRICAL TEST RESULTS. THE PULSE GENERATOR MODULE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2013 INDICATING THAT THE EXPLANTED GENERATOR WAS AVAILABLE FOR RETURN. THE GENERATOR WAS RECEIVED BY THE MANUFACTURER ON (B)(6) 2013, HOWEVER PRODUCT ANALYSIS HAS NOT BEEN COMPLETED TO DATE. THE RETURN PRODUCT FORM INDICATED THE REPLACEMENT ON (B)(6) 2012 WAS PROPHYLACTIC.

    Description of Event or Problem · 1

    THE IMPLANT CARD WAS RECEIVED BY THE MANUFACTURER AND CONFIRMED THE GENERATOR REPLACEMENT SURGERY ON (B)(6) 2012. THE REASON FOR REPLACEMENT WAS MARKED AS PROPHYLACTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7824 PULSE GEN MODEL UNK GENERATOR LYJ CYBERONICS, INC. 10X NI

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR