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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 104 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 104 GENERATOR Back to Search Results
Model Number 104
Device Problems No Device Output ; Device Operates Differently Than Expected
Event Date 08/18/2011
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

It was reported that vns patient was admitted in hospital for cluster of convulsive seizures, and came by ambulance to the epilepsy clinic for checking the vns and anti-epileptic drugs. It was reported that patient stated that he could not feel the vns stimulation anymore. The vns system was not interrogated since (b)(6) 2014 due to patient failing to attend clinics. On checking, the magnet was last used on (b)(6) 2015. It was reported that, the near end of service flag was on on (b)(6) 2015. Upon attempt to perform the system diagnostic test, patient began to cough profusely over a period of 2- 3mins, with reddening of the face and hyperventilation. The vns system could not be interrogated due to patient distress with coughing. Patient then had a witness seizure lasting 1. 5 min with cyanosis requiring rescue medication and oxygen. When the seizure had ceased, patient began again to cough every 40 seconds or so. The vns system was re interrogated and the output and magnet mode current whereas programmed during the last follow up in (b)(6) 2014. A copy of patient notes were provided with patient settings indicating an increase in seizures on (b)(6) 2011 and on (b)(6) 2011. Attempts for additional relevant information have been unsuccessful to date.

 
Event Description

Further information was received from the nurse, indicating that no chest xray was performed in the referring hospital. It was reported that a battery replacement surgery is planned. The nurse indicated that seizure control has deteriorated with vns battery failure. It was reported by the nurse that in the past, she has witnessed clinically seizures for that patient as an inpatient which have resulted in cyanosis. Whether this has been a feature of seizures in recent years is unknown; the patient did not give a good description of seizures. It was reported by the nurse that the vns stimulation did most definitely result in excessive coughing and hyperventilation which seemed to proceed this seizure witnessed.

 
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Brand NamePULSE GEN MODEL 104
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key5229094
Report Number1644487-2015-06472
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Type of Report Followup
Report Date 10/23/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/17/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2013
Device MODEL Number104
Device LOT Number201683
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/18/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2011
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: 11/17/2015 Patient Sequence Number: 1
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