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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
Device Problems Connection Problem; Connector Pin
Event Date 04/01/2009
Event Type  Malfunction  
Event Description

It was reported that a vns pt rec'd a high impedance warning during device diagnostic testing. The pt's treating vns therapy physician indicated that the pt had been unable to perceive vns stimulation and that her lead had recently become visible under the skin of her neck prior to receiving high impedance results. The physician indicated that device diagnostics had been performed a month prior to these results and had confirmed proper device function, and the pt experienced a tonic clonic seizure prior to the onset of these events, but that she was unsure whether this has been a contributing factor. X-rays of the pt's device were rec'd and during a review of these images, it was identified that the pt's lead connector pin did not appear to have been fully inserted within the generator's connector block. The pt will reportedly undergo exploratory surgery by the end of the month.

 
Manufacturer Narrative

Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, lead pin not fully inserted past the connector block of generator.

 
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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 Key1461100
Report Number1644487-2009-00846
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/22/2009
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/19/2009
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2011
Device MODEL Number302-20
Device LOT Number2084
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received04/22/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/01/2008
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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