BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 304

    MDR report key: 3162932 · Received June 11, 2013

    Report

    Report Number
    1644487-2013-01742
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 16, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED STERILIZATION FOR BOTH THE GENERATOR AND LEAD PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    THE PATIENT HAD GENERATOR AND LEAD REPLACEMENT SURGERY ON (B)(6) 2013 AS CAPTURED IN MANUFACTURER REPORT NUMBER: 1644487-2013-01380. CLINIC NOTES DATED (B)(6) 2013 INDICATED THAT THE PATIENT CONTINUED TO HAVE COUGHING EPISODES AND PAROXYSMS OF EVENTS WHERE SHE IS POINTING TO HER THROAT. ON EXAM, THE PATIENT HAD INCREASED SALIVATION. THEREFORE, THE VNS WAS TAKEN OFF OF RAPID CYCLING SEVERAL DAYS AGO AND PROGRAMMED AT 1.5 MA. THE SETTINGS ON THIS VISIT WERE THEN PROGRAMMED TO 1.0 MA, 30 SEC ON TIME, 5 MIN OFF TIME, AND 5 HZ FREQUENCY. LATER, CLINIC NOTES DATED (B)(6) 2013 INDICATES THE MOTHER REPORTED IMPROVEMENT IN THE PATIENT¿S CONDITION, BUT THE PATIENT CONTINUED TO EXPERIENCED COUGH AND INTERMITTENTLY ASSOCIATED EMESIS. THE COUGH WAS DESCRIBED AS OCCURRING THROUGHOUT THE DAY, BUT IS MOST NOTABLE AT NIGHT. SHE WAS EVALUATED BY HER PRIMARY CARE PHYSICIAN THE PREVIOUS DAY WITHOUT PROVIDER CONCERNS FOR INTERCURRENT ILLNESS. THE MOTHER REPORTED SIGNIFICANT DIFFICULTIES WITH ORAL FEEDINGS WHICH HAVE WERE ALSO SINCE DEVICE REPLACEMENT AND HAD TIMED PERIODS OF 5 MINUTES DURING WHICH THERE ARE NO DIFFICULTIES FOLLOWED BY COUGH WITH OR WITHOUT EMESIS. THE NEUROLOGIST WAS INFORMED OF THE ISSUES FROM THE TREATING NURSE AND AGREED WITH THE SURGEON¿S RECOMMENDATION FOR A PERIOD OF REST FOR THE VAGUS NERVE. THE VNS OUTPUT CURRENT AND MAGNET CURRENT WERE BOTH TURNED TO 0 MA DURING THE VISIT. THE PLAN WAS TO ALLOW ONE WEEK OF VAGAL NERVE REST. LATER, NOTES DATED (B)(6) 2013 REPORT THAT THE PATIENT WAS ADMITTED WITH A SUPERFICIAL VNS WOUND INFECTION WITH WOUND DISCHARGE. SHE WAS ADMITTED FOR WOUND WASHOUT, EXPLORATION, AND REVISION. NEUROSURGERY DISCHARGE NOTES DATED (B)(6) 2013 INDICATE THE PATIENT WAS ADMITTED WITH DIAGNOSIS OF SURGICAL WOUND DEHISCENCE STATUS POST-VNS REPLACEMENT, WITH POOR ORAL INTAKE. THE PATIENT WAS DISCHARGED ON (B)(6) 2013 WITH DIAGNOSIS OF SURGICAL WOUND DEHISCENCE STATUS POST-VNS REPLACEMENT, LEFT VOCAL CORD PARALYSIS, AND POOR ORAL INTAKE. THE HOSPITAL COURSE NOTES INDICATE THE PATIENT HAD STIMULATOR REPLACEMENT ON (B)(6) 2013 DUE TO ¿VNS MALFUNCTION,¿ AS CAPTURED IN MANUFACTURER REPORT NUMBER: 1644487-2013-01380. THE PATIENT PRESENTED TO THE CLINIC ON (B)(6) 2013 WITH SLIGHT SEPARATION OF THE WOUND AND SMALL AMOUNT OF WHITE DRAINAGE FOR ONE DAY. THE MOTHER DENIED ANY FEVERS AND SEIZURES. THE PATIENT WAS HAVING A LOT OF GAGGING AND HAS NOT BEEN TOLERATING ANY FOOD INTAKE. SHE LOST A FEW POUNDS IN THE PRIOR FEW DAYS. AN ENT PERFORMED A LARYNGOSCOPIC EXAM ON THE PATIENT ON (B)(6) 2013 WHICH DEMONSTRATED PARALYZED LEFT VOCAL CORD IN THE PARAMEDIAN POSITION WITH MILD PARYNGOMALACIA. THE PATIENT WAS TAKEN TO THE OPERATING ROOM ON (B)(6) 2013 FOR A WOUND WASHOUT AND REVISION. HER WOUND WAS ONLY SUPERFICIALLY DEHISCED AND THERE WAS NO PURULENT MATERIAL SEEN. AN NG TUBE WAS PLACED INTRAOPERATIVELY FOR NUTRITIONAL SUPPLEMENTAL. DURING THE COURSE OF HER HOSPITALIZATION, SPEECH THERAPY AS WELL AS A DIETARY CONSULT WAS OBTAINED. SERUM ELECTROLYTES WERE MONITORED TO ENSURE THE PATIENT DID NOT DEVELOP ANY ELECTROLYTE IMBALANCES FROM RE FEEDING SYNDROME. PER SPEECH THERAPY EVALUATION, THE PATIENT WAS TO BE CONTINUED ON NG FEEDS. INTRAOPERATIVE CULTURES OF HER WOUND WERE NEGATIVE FOR BACTERIAL GROWTH. THE PLAN WAS TO COMPLETE A 7 DAY COURSE OF KEFLEX. THE PATIENT¿S MOTHER WAS INSTRUCTED HOW TO PERFORM THE NG TUBE FEEDS. AT TIME OF DISCHARGE, THE PATIENT WAS AFEBRILE, VOIDING, TOLERATING HER NG TUBE FEEDS, HAD GOOD PAIN CONTROL AND AT HER NEUROLOGICAL BASELINE. THE PLAN WAS FOR THE PATIENT TO BE ADMITTED FOR LONG TERM MONITORING WHICH TIME SPEECH THERAPY WILL BE RE-EVALUATING HER SWALLOWING FUNCTION. ATTEMPTS FOR ADDITIONAL INFORMATION ARE IN PROGRESS BUT HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261851 LEAD MODEL 304 LEAD LYJ CYBERONICS INC 304-20 3483

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention