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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Date 03/11/2011
Event Type  Injury  
Manufacturer Narrative

 
Event Description

The patient's current treating physician indicated that there is no concern about the vns system.

 
Event Description

Clinic notes dated (b)(6) 2103 indicated that this patient¿s device was disabled in 2011 because it was felt that it was making her heart rate drop. It was turned on except for the fact that she was able to swipe the magnet whenever she felt a seizure coming on. The patient was not receiving a continuous daily stimulation. When the vns and medication were discontinued, the patient did well. Review of programming history showed that the device was disabled on (b)(6) 2011.

 
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Brand NamePULSE GEN MODEL 102
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3262884
Report Number1644487-2013-02317
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/09/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/05/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date05/31/2007
Device MODEL Number102
Device LOT Number013345
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received08/26/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/06/2005
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: 08/05/2013 Patient Sequence Number: 1
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