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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 01/01/2010
Event Type  Injury  
Event Description

It was initially reported by the patient that she was having an increase in depressive symptoms. She indicated that she was now in the hospital. She stated she had not had her vns system checked since 2006. A search was performed in the manufacturer's programming history database and a battery life estimation resulted in approximately 6. 05 years remaining until eri=yes, which is likely if the patient has not been since 2006. The patient was last seen on (b)(6)2006. Last diagnostics were performed on (b)(6)2006, which were within normal limits.

 
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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 Key1828529
Report Number1644487-2010-02023
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation PATIENT
Type of Report Initial
Report Date 08/05/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/03/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2007
Device MODEL Number102
Device LOT Number014460
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received08/05/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/01/2005
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: 09/03/2010 Patient Sequence Number: 1
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