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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. LEAD MODEL UNKNOWN Back to Search Results
Event Type  Malfunction  
Event Description

A vns treating physician in (b)(6) reported that they had a pt that had undergone a right sided vns implantation after a left sided lead break. Good faith attempts are underway for further details about the reported event.

 
Manufacturer Narrative

Device info is suspected but did not cause or contribute to a death or serious injury.

 
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Brand NameLEAD MODEL UNKNOWN
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key1952051
Report Number1644487-2011-02958
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/06/2010
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/04/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received12/06/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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