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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102

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CYBERONICS, INC. PULSE GEN MODEL 102 Back to Search Results
Model Number 102
Event Date 05/20/2013
Event Type  Injury  
Event Description

A vns patient's mother called and reported that about a week ago around (b)(6) 2013 her child had a different seizure than ever before where he was confused during the seizure and she called ems but pt was not transported to the emergency room. Their seizures are still below baseline. The patient's last clinic visit prior to that date was (b)(6) 2013: clinic notes were received for review that reported. His seizures have been very well controlled with the vagus nerve stimulator which was implanted back in 2006, for almost one year, he did very well without recurrent seizures, but when he had l3-l4 laminectomy about 3 months ago, he had another seizure but since the last visit, he has been seizure fee. His vns was increased on his last visit. He's been tolerating the current dosage of medications which have not changed for a while. He did not have any significant side effects from the current settings of the vagus nerve stimulator. Good faith attempts are underway to determine the relationship of their change in seizure type to their vns device. Their device is not at end of battery life. The patient has been scheduled for a surgery consult for 6/25/2013. The outcome of the visit is pending. Unknown at this time if the patient will have their generator replaced.

 
Event Description

On (b)(6) 2013 it was reported that the patient underwent prophylactic generator replacement that day. The explanted generator has not been returned for product analysis to date.

 
Event Description

The explanting facility discarded the explanted device; therefore, no analysis can be performed.

 
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Brand NamePULSE GEN MODEL 102
Type of DevicePULSE GEN MODEL 102
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3191385
Report Number1644487-2013-01933
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Other,Consumer,Health Professional,Company Representative
Reporter Occupation OTHER CAREGIVERS
Type of Report Initial,Followup,Followup
Report Date 05/28/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/26/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2007
Device MODEL Number102
Device LOT Number014460
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received07/30/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/08/2005
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: 06/26/2013 Patient Sequence Number: 1
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