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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 05/17/2010
Event Type  Malfunction  
Event Description

A vns pt's treating physician reported that system diagnostic testing on one of his vns pt's yielded output: limit, dcdc 7 and lead impedance high, eri no. Normal mode diagnostics resulted in the same. Additionally, it was reported the pt has been having a little shocking sensation sometimes occurring when she turns her head also occurring spontaneously. The pt denies any trauma, which may have caused the high impedance. The physician was provided recommendations to program the vns off. At this time, good faith attempts have been unsuccessful for further details about the reported event.

 
Manufacturer Narrative

Device malfunction suspected, but did not cause or contribute to a death or serious injury.

 
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Brand NameLEAD MODEL 302
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste. 600
houston , TX 77058
2812287200
MDR Report Key1773831
Report Number1644487-2010-01412
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 05/17/2010
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/15/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2009
Device MODEL Number302-20
Device LOT Number200340
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received05/17/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/01/2006
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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