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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 102 Back to Search Results
Model Number 102
Event Date 08/04/2010
Event Type  Injury  
Event Description

It was reported through clinic notes dated (b)(6) 2010, that a physician noted that the pt's depression worsened when her device was not working previously. F/u was made with the pt's treating nurse who indicated that the pt's device had not been disabled at any other time other than at reported high lead impedance (reported in mfr. Report 1644487-2010-02012). The nurse also indicated that it is unk if the pt's depression ever elevated above pre-vns baseline as the pt sees a psychiatrist for her depression. Furthermore, if the pt experienced an increase in depression in the past, the nurse was not able to tell what contributed to the event.

 
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Brand NamePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste. 600
houston , TX 77058
2812287200
MDR Report Key2005792
Report Number1644487-2011-00361
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 01/26/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/25/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2009
Device MODEL Number102
Device LOT Number017152
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received01/26/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/2007
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: 02/25/2011 Patient Sequence Number: 1
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