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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 Device Inoperable
Event Date 10/20/2015
Event Type  Malfunction  
Event Description

It was reported that the patient's vns magnet mode is not thought to be functioning. It was reported that the patient cannot feel magnet activations and the magnet swipes are (b)(6) 2015 and one on (b)(6) 2015. The patient also experienced a cluster of seizures on (b)(6) 2015 that the magnet was not able to abort. No additional relevant information has been received to date.

 
Event Description

Additional information was received that the patient is able to inhibit stimulation by holding the magnet over the generator. Proper magnet swiping technique was verified and the magnet was not deep in the tissue or tilted. Troubleshooting revealed that the patient swiped her magnet and did feel stimulation, and the magnet swipe was registered upon interrogation. Information was received that the magnet is not often useful in aborting the patient's seizures because the patient normally cannot swipe the magnet in time, not suspected to be caused by a generator issue. It was reported that there are no longer any suspected issues with the patient's generator. No additional relevant information has been received to date.

 
Manufacturer Narrative

Corrected data: this information was inadvertently left off of supplemental mfr. Report #01. Corrected data: "it was reported that the patient was experiencing shortness of breath with device stimulation. Device diagnostics were within normal limits and device settings were reduced. The physician believes the patient is overly sensitive to device stimulation. The patient was reported to be fine after device settings were reduced. " this information was inadvertently left off of supplemental mfr. Report #01.

 
Event Description

It was reported that the patient was experiencing shortness of breath with device stimulation. Device diagnostics were within normal limits and device settings were reduced. The physician believes the patient is overly sensitive to device stimulation. The patient was reported to be fine after device settings were reduced. It was reported by the patient's mother that they want the vns explanted due to painful stimulation in the neck, breathing difficulties with device stimulation during exertion. The mother reported that since the patient has had difficulty tolerating stimulation and they had not noticed any efficacy the device was disabled for three months. The device was then programmed back on to a very low setting. The stimulation is now tolerable. The mother reported that recently the patient has experienced a change in seizure type and has also had a transient ischemic attack which has contributed to her current state. No known surgical interventions have been performed to date. Attempts to obtain additional relevant information have been unsuccessful to date.

 
Event Description

It was reported that vns was never efficacious per the mother. Per the mother, the seizures have never changed post-implant. No surgical intervention has occurred to date. No additional relevant information has been received to date.

 
Event Description

Follow-up with the surgeon's office revealed that the mother called their office in (b)(6) 2016 and wanted the patient to get a head mri due to increased headaches (with no allegation against vns). However, they had not seen the patient since 2014. The mother had mentioned wanting a mri and vns explant to the last treating physician's office. No surgical intervention has occurred to date. 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 Key5216170
Report Number1644487-2015-06396
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Followup,Followup,Followup,Followup
Report Date 10/20/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/11/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2016
Device MODEL Number105
Device LOT Number202963
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received09/14/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/12/2014
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: 11/11/2015 Patient Sequence Number: 1
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