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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/17/2017
Event Type  Injury  
Event Description

A patient's mother reported that a patient received stronger stimulation with a magnet swipe. The magnet stimulation reportedly made the patient's seizure worse. No additional relevant information has been received to date.

 
Manufacturer Narrative

Outcomes attributed to adverse event, corrected data: initial report inadvertently did not include known medical intervention describe event or problem, corrected data: initial report inadvertently did not include known medical intervention and full list of patient events event problem codes, corrected data: initial report inadvertently did not include full list of patient events. Report source, corrected data: initial report inadvertently did not include consumer. (b)(4).

 
Event Description

It was reported that the patient swiped her magnet again after a dosing appointment where her settings were increased, and she experienced a head tilt to the left, a cold sensation, shaking, painful stimulation, nausea, and pallor with magnet stimulation. This reportedly occurred a few more times, but each time was less intense; however, these events made the patient afraid to use her vns magnet. A company representative and the physician met with the patient and her mother. During the clinic visit, the patient's magnet pulse width setting was reduced from 500 to 250 microseconds. The patient was then able to tolerate stimulation, and the events resolved. Diagnostics were within the normal limits. Use of the magnet had made the patient anxious since she reportedly did not expect to feel stimulation as strongly as she did following the initial settings increase. The physician believed that the reported events the patient's anxiety contributed to the adverse events she experienced with magnet stimulation. Stress was also a trigger for the patient, so the physician believed that the combination of original settings and the patient's anxiety also contributed to the change in seizure intensity. No additional relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 106
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 Key7122957
Report Number1644487-2017-05012
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Initial
Report Date 01/12/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/15/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/01/2018
Device MODEL Number106
Device LOT Number5082
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/12/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/03/2016
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: 12/15/2017 Patient Sequence Number: 1
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