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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL UNKNOWN GENERATOR Back to Search Results
Event Type  Malfunction  
Event Description

It was reported by a patient that he had experienced "irregular stimulation" and painful stimulation with his vns device. The patient reported that the generator (unknown when implanted and reportedly explanted in (b)(6) 2016) caused him to have painful stimulation in the left neck and armpit, and the "irregular stimulation" to his vagus nerve caused his body to "forget how to breathe" while sleeping. The patient also reported that he had to then start using oxygen at night to make sure his body continues to breathe while he sleeps. Reportedly, the neurologist informed the patient that the irregular stimulation from the generator caused his nerve to become dependent on the stimulation to remember to breathe, so the neurologist continues to suggest that the patient be re-implanted with vns. However, the patient refused to be re-implanted after the third generator was explanted. The patient kept the third generator after explant, and the lead was left implanted. The patient also reported that vns did help reduce his seizures, but he has stress-induced grand mal seizures which were exacerbated by the painful stimulation and distress over having "defective vns devices. " he tried to hurt himself as well because of the painful stimulation and distress. No further relevant information has been received to date.

 
Event Description

The patient reported that his third generator malfunctioned and shocked his jaw and teeth to the point where he had to get dentures. He reported that he could not get the lead removed where he lived due to the damage on his nerve from stimulation. Neither of the patient's previous surgeons were aware of a third generator being implanted. Attempts for further information were unsuccessful to date.

 
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Brand NamePULSE GEN MODEL UNKNOWN
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 Key6031775
Report Number1644487-2016-02378
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation PATIENT
Type of Report Followup
Report Date 09/20/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/14/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/07/2016
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: 10/14/2016 Patient Sequence Number: 1
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