BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3161364 · Received June 11, 2013

    Report

    Report Number
    1644487-2013-01736
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 17, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN THE PA LAB, THE DEVICE OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24-HRS, WHILE THE GENERATOR WAS PLACED IN A SIMULATED BODY TEMPERATURE ENVIRONMENT. RESULTS SHOWED NO SIGNS OF VARIATION IN THE PULSE GENERATOR¿S OUTPUT SIGNAL AND DEMONSTRATED THAT THE DEVICE PROVIDED THE EXPECTED LEVEL OF OUTPUT CURRENT FOR THE ENTIRE MONITORING PERIOD. THE PULSE GENERATOR DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. IN ADDITION, A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR 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

    THE COMPANY REPRESENTATIVE REPORTED THAT THE EXPLANTED DEVICE WAS AVAILABLE FOR RETURN. THE GENERATOR WAS RECEIVED BY THE MANUFACTURER ON (B)(4) 2013. HOWEVER, PRODUCT ANALYSIS HAS NOT BEEN COMPLETED TO DATE.

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2013 WERE RECEIVED FOR THE PATIENT¿S REFERRAL FOR SURGERY WHICH INDICATED THE PATIENT PRESENTED TO THE NEUROLOGIST WITH COMPLAINTS OF VNS DISCOMFORT. THE PATIENT REPORTED THAT SHE DID NOT FEEL THE VNS WAS WORKING, AND AT THE SAME TIME, SHE FELT THAT THE VNS IS CAUSING PAIN THAT GOES FROM THE AREA OF THE GENERATOR TO THE NECK. THE DISCOMFORT WAS CONSTANT. THE EPISODE STARTED IN THE PRIOR 7 DAYS. THE ALTERED MENTAL STATUS DEVELOPED GRADUALLY. THE PROBLEM IS UNCHANGED. THERE WAS LEFT-SIDED FOCALITY NOTED WITH ASSOCIATED SYMPTOMS INCLUDING NECK PAIN. PAST TREATMENTS INCLUDED ACETAMINOPHEN, BUT THE TREATMENT DID NOT PROVIDE RELIEF. THE NEUROLOGIST REPORTED IN THE NOTES THAT HE PERSONALLY REVIEWED THE CSR X-RAY, AND THE STUDY SHOWED NORMAL LEAD PLACEMENT WITH THE GENERATOR ¿VERY LOW IN THE BREAST.¿ THE CHEST PA AND LATERAL X-RAY REPORTED INDICATED THE REASON FOR REVIEW WAS ¿NERVE STIMULATOR MALFUNCTION¿ WITH PORTABLE CHEST COMPARISON FROM (B)(6) 2013. THE LEAD APPEARED UNCHANGED SINCE THE COMPARISON EXAMINATION, AND THE LEAD APPEARED INTACT. THE VNS WAS INTERROGATED, AND THE IMPEDANCE WAS NORMAL. THE VNS WAS WORKING PROPERLY PER THE NOTES. THE VNS WAS TURNED OFF, AND THE PATIENT CONTINUED TO COMPLAIN OF DISCOMFORT. THE PATIENT ALSO COMPLAINED OF BREAKTHROUGH SEIZURES. THE PATIENT¿S ANTI-SEIZURE MEDICATION WAS INCREASED AND THE PATIENT WAS PRESCRIBED MEDICATION FOR THE PATIENT. SHE WAS ALSO REFERRED TO NEUROSURGERY FOLLOW-UP. CLINIC NOTES DATED (B)(6) 2013 FROM THE SURGEON¿S OFFICE REVEALED THAT THE PATIENT WAS EXPERIENCING INCREASED SHOCKING IN HER LEFT BREAST AROUND THE GENERATOR IMPLANT, BUT SHE WAS STILL GETTING CONTROL OF HER SEIZURES. THIS PROGRESSED UNTIL IT BECAME SEVERE ENOUGH THAT SHE WENT BACK TO THE NEUROLOGIST, AND HE DID AN X-RAY THAT SHOWED THE GENERATOR HAD ¿MIGRATED DEEP INTO THE BREAST AND APPEARED TO BE STRETCHING ON THE ELECTRODE. THE ELECTRODE REMAINED IN GOOD POSITION.¿ THE NEUROLOGIST TURNED THE DEVICE OFF, AND THE PAIN RESOLVED BUT SINCE THEN, SHE HAS HAD INCREASING SEIZURE FREQUENCY AND SEVERITY INDICATING THE EFFICACY OF THE DEVICE. THEREFORE, THE SURGEON INDICATED THAT THE PATIENT WOULD REQUIRE ELECTRODE REVISION. THE SURGEON REPORTED THAT THE SHOCKING INDICATES THAT THERE IS ¿PROBABLY DAMAGE TO THE ELECTRODE LEAD AND WE WILL INTERROGATE THIS AT THE TIME OF SURGERY.¿ THE PATIENT WAS REFERRED FOR GENERATOR REPLACEMENT SURGERY WITH POSSIBLE LEAD REPLACEMENT IF WARRANTED. FOLLOW UP WITH THE NEUROLOGIST¿S OFFICE REVEALED THAT THE DEVICE WAS TURNED OFF ON (B)(6) 2013. THE BELIEVED CAUSE FOR THE PAIN IN THE CHEST AND NECK WAS DUE TO THE GENERATOR BEING MISPLACED. THE PATIENT BELIEVES A CHILD PUSHED ON THE GENERATOR MAKING IT MOVE. THE PATIENT THEREFORE HAD SURGERY TO MOVE THE GENERATOR. ATTEMPTS TO THE SURGEON TO DETERMINE IF A NON-ABSORBABLE SUTURE TO SECURE THE GENERATOR TO THE FASCIA HAVE BEEN UNSUCCESSFUL TO DATE. THE PATIENT HAD GENERATOR REPLACEMENT SURGERY ON (B)(6) 2013. GOOD FAITH ATTEMPTS FOR PRODUCT RETURN ARE UNDERWAY BUT HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT A NON-ABSORBABLE SUTURE USED TO SECURE THE GENERATOR TO FASCIA DURING IMPLANTATION OF THE DEVICE DURING IMPLANT SURGERY ON (B)(6) 2011.THE COMPANY REPRESENTATIVE REPORTED THAT THE PRODUCT DISPOSITION IS UNCLEAR AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263136 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 2889

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention