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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 09/27/2011
Event Type  Injury  
Event Description

Additional information was received on (b)(6) 2011 where it was reported that the physician did not believe any of the events (weight loss, seizures, sleep disturbances, or loss of appetite) were related to vns therapy or surgery as the device was not programmed on at the time the events occurred. Per the physician, the patient was taking adhd which caused all the events. Once the physician lowered the dosage of the adhd, the symptoms resolved. The device is now programmed on and has been titrated twice without any issues. No additional information was provided.

 
Event Description

It was reported that a patient implanted in (b)(6) 2011 was experiencing an increase in seizures in number and intensity since device implant. The patient had about 2 grand mal seizures recently which did not routinely occur prior to implant. The patient has not been sleeping, not eating, and has lost (b)(6) since implant. The device has been programmed on and the physician has begun to titrate the patient's settings. Good faith attempts to obtain additional information will be made.

 
Manufacturer Narrative

 
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Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
CYBERONICS INC
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2342095
Report Number1644487-2011-02791
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/27/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/18/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2012
Device MODEL Number103
Device LOT Number2918
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received11/23/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/14/2011
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: 11/18/2011 Patient Sequence Number: 1
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