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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 103

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CYBERONICS INC PULSE GEN MODEL 103 Back to Search Results
Model Number 103
Event Date 08/23/2012
Event Type  Injury  
Event Description

Analysis of the vns generator was completed. No anomalies were identified, and the generator performed per specifications. The generator was not at end of service. Manufacturer follow-up with the reporter revealed the patient's seizures have improved since the vns generator was replaced.

 
Event Description

Manufacturer follow up with the explanting hospital initially indicated the explanted vns generator was not available, but it was later returned on (b)(6) 2013 and is pending analysis. A manufacturer's implant card was also received indicating the reason for generator replacement was due to battery depletion. Diagnostics with the new generator and resident lead were within normal limits.

 
Event Description

Reporter indicated that a patient was having increased seizures and a new seizure type of drop seizures. The vns was noted to be at end of service, but was still functioning as intended. The increased seizures are felt to be due to the generator nearing end of service, and the level of the seizure increase and seizure type is not known. The cause of the new seizure type (drop seizures) is not known. The patient had vns generator replacement surgery performed on (b)(6) 2012. Attempts for additional information and return of the explanted generator are in progress.

 
Manufacturer Narrative

 
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Brand NamePULSE GEN MODEL 103
Type of DevicePULSE GEN MODEL 103
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 herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2887869
Report Number1644487-2012-03469
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/28/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/27/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2011
Device MODEL Number103
Device LOT Number201282
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/10/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/05/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/03/2009
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: 12/27/2012 Patient Sequence Number: 1
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