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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 302

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CYBERONICS - HOUSTON LEAD MODEL 302 Back to Search Results
Model Number 302-20
Device Problem Low impedance
Event Date 03/17/2010
Event Type  Malfunction  
Event Description

It was initially reported from social media post that a patient¿s son did not see any benefit from the vns device. At this point patient information was unknown. Additional information was received from the patient¿s mother which identified the patient whose vns was said to be ineffective. She said that the generator was dead and that vns had "failed" and did not help her son enough to agree to have the generator replaced. She said that the patient's physician had told her that explant would run the risk of infection and that it would be safer to keep the system implanted. The programming history database was reviewed and showed a possible short circuit condition. It appears that there was a dramatic drop in impedance from (b)(6) 2009 dcdc 2 to (b)(6) 2010 showing dcdc 0. Along with the allegation that the device was ineffective, this shows there may have been a short circuit condition present. No additional information has been received to date.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
rachel kohn
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key8491506
Report Number1644487-2019-00671
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,OTHER
Reporter Occupation
Type of Report Initial
Report Date 04/08/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/08/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/10/2008
Device MODEL Number302-20
Device LOT Number1090
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/14/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/11/2005
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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