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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 104 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 104 GENERATOR Back to Search Results
Model Number 104
Event Date 12/01/2015
Event Type  Injury  
Event Description

On (b)(6) 2015 it was reported by the patient's mother that the patient has had recent unusual seizure activity that started over the last few months (that she thinks are simple partial seizures) and thinks are possibly related to the device function. She wants the patient to see the physician to check the vns device. The patient's mother went to the physician's office and reported that she wants the vns "worked on". Per the nurse, the mother did not report any change in the patient's seizures. The patient's mother later reported that the patient was having an increase in partial seizures and that the vns generator was not delivering the appropriate amount of therapy. She stated that she thinks the physician "switched the battery to save settings. " the mother feels that the increase in seizures is above pre-vns baseline levels. The patient's mother stated that there is a change in behavior; the mother described this as stiffening of arms and right side of body, quick arm and hand movements, incontinence, and unusual desire for excessive water. She said these were all things that were well controlled and are now occurring more frequently. The mother indicated that there has been no change in medication.

 
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Brand NamePULSE GEN MODEL 104
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key5304878
Report Number1644487-2015-06783
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Report Date 12/07/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/16/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2015
Device MODEL Number104
Device LOT Number202677
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received12/07/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/15/2013
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: 12/16/2015 Patient Sequence Number: 1
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