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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 104 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 104 GENERATOR Back to Search Results
Model Number 104
Event Date 12/01/2010
Event Type  Injury  
Event Description

Additional information was received indicating that any increase in seizures that the patient was experiencing prior to the replacement has now returned to their vns baseline. Product analysis on the generator was completed. The reported low battery conditions were duplicated in the pa lab. Results of diagnostic testing indicate that the battery status is at a neos=yes condition. The battery was found to be partially depleted. There were no conditions found during product analysis of the generator that would affect the generator performance.

 
Event Description

Additional information was received from the patient's treating neurologist indicating that the reported new seizure type was thought to be non-epileptic by an epileptologist. The prolonged seizures were part of the patient's usual seizure pattern, and the reported increase in seizures was above the patient's pre-vns baseline. The neurologist indicated; however, that she did not feel that any of these events were related to vns.

 
Event Description

It was reported through clinic notes received on (b)(4) 2011 that the patient had developed a new seizure type in (b)(6) 2010, had experienced two prolonged seizures which he was hospitalized for on (b)(6) 2011, and was experiencing an increase in seizures on (b)(6) 2011. It was reported that the patient had experienced 16 seizures in the last month compared to 6 seizures a month prior to that appointment. During the patient's follow up visit on (b)(6) 2011, it was reported that the patient's generator was showing the intensified follow-up indicator. The patient was referred for and underwent a generator replacement procedure on (b)(6) 2011 due to the ifi flag and the increase in seizures. The explanted generator has been returned, however, product analysis has not yet been complete. Attempts for additional information have been unsuccessful to date.

 
Manufacturer Narrative

 
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Brand NamePULSE GEN MODEL 104
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 Key2335944
Report Number1644487-2011-02734
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/17/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/14/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2011
Device MODEL Number104
Device LOT Number201210
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/03/2011
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/15/2011
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/21/2009
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: 11/14/2011 Patient Sequence Number: 1
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