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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL UNK GENERATOR Back to Search Results
Event Date 01/02/2017
Event Type  Injury  
Event Description

An article was received that reported multiple adverse events and a malfunction. The current report captures the adverse events associated with the generator. Mfr. Report # 1644487-2017-04155 captures the malfunctions reported by the article. Mfr. Report # 1644487-2017-04154 captures adverse events associated with the lead. There was one intraoperative adverse event associated with the generator. This patient experienced transient asystole intraoperatively. This event resolved without treatment and did not require cardiopulmonary resuscitation. There were three reported post-surgical complications related to the generator. There was one patient that presented with wound dehiscence one week post-surgery that was managed surgically. Another patient presented with an infection at both generator and neck sites; this patient had full recovery after being treated aggressively, first with iv antibiotics for one week and second with oral antibiotics for another week. The last patient experienced post-operative status epilepticus that required 3 days intubation and icu admission; this was most probably related to general anesthesia used during surgery. The article reported that 10 patients experienced laryngeal side effects associated with stimulation (coughing, hoarseness and shortness of breath) that were proportional to amplitude, frequency and duration of stimulation. These patients all presented with a significant increase in vocal handicap index. These patients were found to have decreased left cord mobility that was more significant with vocal cord abduction. The left cord in the resting position was shorter and more medially-positioned than the right vocal cord. None had complete vocal cord paralysis and their voice changes did not affect their ability to communicate and shortness of breath was mild. None needed medical or surgical treatment. Vocal hoarseness resolved in patient's no longer receiving therapy. One patient experienced an increase in seizures with vns therapy. The patient' caregivers requested vns removal. No further relevant information has been received to date.

 
Event Description

The surgeon indicated that in the study there was never a problem in the generators or their ability to deliver therapy. No further relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL UNK
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 Key6723189
Report Number1644487-2017-04153
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Report Date 09/05/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/18/2017
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
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received08/09/2017
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: 07/18/2017 Patient Sequence Number: 1
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