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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL UNK

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CYBERONICS, INC. PULSE GEN MODEL UNK Back to Search Results
Event Date 01/01/2003
Event Type  Injury  
Event Description

During the review of an article titled "treatment of vns-induced laryngospasm with botulinum toxin", it was noted that the vns patient in the observational study experienced severe sleep obstructive sleep apnea. "a polysomnogram (psg) revealed an apneahypopnea index (ahi) of 25, indicating moderate to severe obstructive sleep apnea. The respiratory events resulted in frequent arousals, oxygen desaturations, and significant sleep disruption (sleep efficiency 78%; expected values 90%). The psg showed periodic chin emg activity that coincided with airflow limitations. This pattern lasted 30 seconds and repeated approximately every 80 seconds, with normal intervening respiration. Thus, vns-induced laryngospasm appeared to cause sleep apnea in this patient. " the patient was prescribed use of cpap/bpap to help with the reported event but the "positive airway pressure was unsuccessful in alleviating sleep-disordered breathing. " it was indicated that adjustments to vns settings were made to decrease stimulation to help with the reported event but the suboptimal seizure control made the approach impractical. "first direct laryngoscopy verified that the vns caused the laryngospasms. Following deactivation of the device, the left thyroarytenoid muscle was injected with 0. 4 ml botulinum toxin (0. 125 u/0. 1 ml saline). The vns was then reactivated. Within a few weeks, symptoms improved markedly. A psg performed 1 month after injections revealed an ahi of 3, few oxygen desaturations, and a 90% sleep efficiency. The characteristic emg artifact seen previously did not occur. Thus, botulinum toxin injections ameliorated sleep-disordered breathing to clinically adequate levels. This effect lasted approximately 4 months, when symptoms recurred (ess 21). " although, it was not stated if the patient received repeat injections of the botulinum toxin, it was indicated in the article that they may be needed as the treatment loses effectiveness. Good faith attempts to obtain additional information from the primary authors have been made, but no additional information has been received to date.

 
Manufacturer Narrative

Article citation: kumar, s; sharafkhaneh, a; edmonds, j, et al. Treatment of vns-induced laryngospasm with botulinum toxin. Neurology. 73. 1808-10. 2009.

 
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Brand NamePULSE GEN MODEL UNK
Manufacturer (Section D)
CYBERONICS, INC.
houston TX
Manufacturer Contact
nydia grimes
100 cyberonics blvd. ste. 600
houston , TX 77058
2812287200
MDR Report Key1567250
Report Number1644487-2009-02876
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Literature,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/23/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/23/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received11/23/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/23/2009 Patient Sequence Number: 1
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