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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR Back to Search Results
Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/13/2015
Event Type  Injury  
Event Description

It was reported that the patient visited the er as she was experiencing an altered perception of stimulation as it was stated she could feel it, go off, every 30 seconds; however, the patient claimed the neurologist had set the device to go off every 3 minutes. It was also noted that this stimulation was painful. During this visit to the er, she was given ativan for her anxiety. The patient visited the er the following day with the same complaints. She also stated the ativan was not helping; however, later she states that she felt much better after her shot of ativan. The patient then stated that she does not usually have an aura, but she now has a sense of smell and burnt toast almost all the time recently. It was also reported that the patient has some discomfort earlier in her chest radiating to the left shoulder. There was no additional information on the chest pain other than it was not related to exertion or breathing. The patient's pain was treated with dilaudid. It was noted that the patient's device has been checked several times since it was implanted in (b)(6) of 2014 and there have been no issues. Attempts to obtain additional relevant information have been unsuccessful to date.

 
Manufacturer Narrative

The udi number was inadvertently left off of the initial mfr. Report. (b)(4).

 
Event Description

It was later reported by the physician that he does not believe the patient's reported pain is related to vns. It was also reported that system diagnostics were normal and the impedance value was normal. It was noted this patient has a number of psychological issues. No other additional relevant information has been reported to date.

 
Manufacturer Narrative

Results; this information was inadvertently left off of the supplemental #02 mfr. Report.

 
Event Description

It was reported by the patient's following physician that the er physician had said the patient's smell of burnt toast was not related to seizures. However, it was noted by the patient's following physician that this was new to the patient after the patient was seen and assessed on (b)(6) 2015. Additionally, the physician explained that the patient has a history of anxiety issues which is the cause of the patient's complaint of the vns device firing too often. No additional relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 105
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 Key5005006
Report Number1644487-2015-05488
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/17/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/14/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/09/2016
Device MODEL Number105
Device LOT Number203165
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/14/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/18/2014
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: 08/14/2015 Patient Sequence Number: 1
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