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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 102R GENERATOR Back to Search Results
Model Number 102R
Event Date 04/01/2014
Event Type  Injury  
Event Description

It was reported that the vns patient was admitted to behavioral center following a suicide attempt. The patient was reported to be doing better. Attempts for additional relevant information have been unsuccessful to date.

 
Manufacturer Narrative

Additional information indicates that the event occurred in (b)(6) 2014.

 
Event Description

Additional information was received stating that the vns patient had a long history of depression with mood changes. The patient had severe depression and attempted suicide in (b)(6) 2014. The patient device was tested during an office visit in (b)(6) 2014 and diagnostic results showed normal device function. The patient's increased depression and suicide attempt were not believed to be related to vns.

 
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Brand NamePULSE GEN MODEL 102R
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 Key4092927
Report Number1644487-2014-02355
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation PATIENT
Type of Report Initial,Followup
Report Date 08/18/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/16/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2013
Device MODEL Number102R
Device LOT Number3024
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received09/18/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/07/2011
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: 09/16/2014 Patient Sequence Number: 1
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