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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 102R

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CYBERONICS INC PULSE GEN MODEL 102R Back to Search Results
Model Number 102R
Event Date 01/01/2011
Event Type  Injury  
Event Description

Product analysis was completed on the explanted vns generator. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

 
Event Description

Reporter indicated vns generator replacement surgery was tentatively scheduled for (b)(6) 2012. The patient later had vns generator replacement surgery performed on (b)(6) 2012. An implant card was received to the manufacturer indicating the replacement was prophylactic. The explanted generator has been returned and is pending product analysis.

 
Event Description

Reporter indicated a vns pt had a dramatic increase in seizures over the last six months. Vns settings were adjusted as an intervention. It is felt the generator battery may be nearing end of service per the reporter. The etiology of the seizure increase is unk, and it is unk if the seizure increase is greater than the pt's pre-vns baseline seizure levels. The pt has multiple seizure types, including generalized seizures, and in general all types were increased per the pt's mother per the reporter. The vns is not at actual end of service, but the pt will be monitored for nearing end of service. Vns generator replacement is not planned at this time. It is not known if the setting change has improved the seizures as the pt will not be seen for two months. A battery estimate performed yielded approx 0. 59 years remaining on the vns battery.

 
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Brand NamePULSE GEN MODEL 102R
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 Key2196563
Report Number1644487-2011-01776
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 07/06/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/03/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date07/31/2006
Device MODEL Number102R
Device LOT Number011190
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/17/2012
Is The Reporter A Health Professional? No
Date Manufacturer Received03/02/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/01/2004
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: 08/03/2011 Patient Sequence Number: 1
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