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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 103 GENERATOR

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CYBERONICS INC PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 01/01/2015
Event Type  Injury  
Event Description

Clinic notes were received for patient¿s generator replacement referral. Notes dated (b)(6) 2015 indicate that the patient is not sure if the vns is functional or not. Vns was interrogated and reprogrammed to higher output current settings on (b)(6) 2015. Additional information was received that the patient questions function of vns as he had been having more seizures than usual. Patient¿s pre-vns baseline is unknown and medications were recently changed. Patient underwent generator replacement on (b)(6) 2015 and the explanted generator was reported to have been discarded.

 
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Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058
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 Key4752215
Report Number1644487-2015-04632
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/14/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/06/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2011
Device MODEL Number103
Device LOT Number201314
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/14/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/08/2010
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: 05/06/2015 Patient Sequence Number: 1
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