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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2017
Event Type  Malfunction  
Event Description

Clinic notes were received for patient, who would like to have her device removed, because she feels she no longer is receiving efficacy from the therapy. Notes dated (b)(6) 2017 indicate that patient's seizure frequency is worse than before over the last several months. Patient reported that the use of the magnet has had no effect in reducing seizure frequency or aborting seizures. Since patient's visit in (b)(6), patient has ben seen several times for vns adjustment. In (b)(6) visit, patient noted that she had increased frequency of seizures and that she has had multiple different types including drop events, convulsions, and starring/spacing. Patient cannot identify any changes in her life or medication use to correspond with this worsening. Patient also tried cbd oil and found it to be somewhat helpful. No additional relevant information has been received.

 
Event Description

Information was received that the patient's seizure increased from (b)(6) to (b)(6) 2017. Vns was returned to original settings by april after being turned off for surgery few months back. Yet the seizures are still worse currently. Per the physician, the relation of the seizures to vns is unclear. Patient's magnet swiping technique was observed to confirm that it is effective in initiating magnet stimulation. Normal mode diagnostic test results were provided with a dcdc - 5. Patient's device was disabled for patient's hysterectomy. Following that, the settings were titrated up to 2. 75 ma. The patient experienced pain in the throat which went away when the settings were decreased to 2. 5 ma. Since then the patient noticed that vns has not helped with her seizures and wanted it removed. Patient saw a neurosurgeon, who recommended that the vns be programmed off to see changes in seizures before removing. The patient did receive benefit from vns initially but has had a lot of stress. The nurse practitioner mentioned that she can't say the increase in seizures is directly related to vns. The seizure rate in comparison to pre-vns baseline is unknown.

 
Event Description

Per the neurologist's note, patient is receiving benefit from device. No known surgical interventions to remove the vns has occurred to date.

 
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Brand NamePULSE GEN MODEL 102
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 Key6822371
Report Number1644487-2017-04377
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 10/19/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/25/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2012
Device MODEL Number102
Device LOT Number2846
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received09/26/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/16/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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