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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302 NONE

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CYBERONICS, INC. LEAD MODEL 302 NONE Back to Search Results
Model Number 302-20
Event Date 12/19/2008
Event Type  Malfunction  
Event Description

It was initially reported that the physician obtained high lead impedance when performing diagnostics on a vns pt's device. The physician requested x-rays and no anomalies were observed. The physician believes that there may be some scarring or there may be a disconnection or break that could not be identified on the x-ray films that is causing the high lead impedance readings. The pt has been referred for surgery to revise the lead as well as have his generator replaced prophylactically at the request of his parents. Follow up with the physician revealed that there was no report of pt trauma or manipulation that could have caused the reported event. The physician did not provide x-rays to manufacturer for review nor did he provide specific diagnostic results. He did state that the pt had also experienced a change in seizure pattern however, he did not know the cause. The pt's previous seizure included left hand and face twitching, but has now changed to upper extremity contractions. The number of seizures has not increased for this pt. The physician adjusted the pt's aed regime as well as his vns programmed settings. Good faith attempts to obtain additional information from the treating physician have been unsuccessful to date.

 
Manufacturer Narrative

Conclusions: device failure is suspected, but did not cause or contribute to a death or serious injury.

 
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Brand NameLEAD MODEL 302
Type of DeviceNONE
Manufacturer (Section D)
CYBERONICS, INC.
houston TX
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key1363931
Report Number1644487-2009-00079
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 01/05/2009
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/15/2009
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number302-20
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received01/05/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/01/2006
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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