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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 01/01/2010
Event Type  Malfunction  
Event Description

It was initially reported by the pt that her depression was worse than before she got vns. The pt indicated that she was seen shortly after her implant and hasn't seen any psychiatrist or other physician since (b)(6) 2009. Her prescribing physician confirmed that the pt was seen shortly after implant ((b)(6) 2009) and had not returned since. The pt was believed to be continuing to have depression, not necessarily an increase in depression. There were no details available about her device settings or diagnostics. The pt was noted to have been 5 yrs with no lab work and was last prescribed some medications for her depression. The pt also has missed her last two appointments. No further details were known at this time since the pt has yet to follow up with them on her depression. A search performed in the mfr's programming history database showed last diagnostics to be within normal limits.

 
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Brand NamePULSE GEN MODEL 103
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key1740248
Report Number1644487-2010-01485
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 05/25/2010
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/24/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2011
Device MODEL Number103
Device LOT Number2300
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received05/25/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2009
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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