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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 07/14/2011
Event Type  Injury  
Event Description

Reporter indicated a patient was having increased seizures that were felt to be due to a depleting vns generator, even though the generator was not at end of service. The generator was replaced prophylactically due to anticipation of a near end of service condition. The patient later had generator replacement surgery performed. The explanted generator has been returned and is pending analysis. Attempts for further information are in progress.

 
Event Description

Product analysis of the vns generator was completed. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator. All attempts to the reporter for further information have been unsuccessful to date.

 
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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 grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2251858
Report Number1644487-2011-02195
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/22/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/16/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2010
Device MODEL Number103
Device LOT Number2151
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/25/2011
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/23/2011
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/11/2008
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: 09/16/2011 Patient Sequence Number: 1
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