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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 303

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CYBERONICS, INC. LEAD MODEL 303 Back to Search Results
Model Number 303-20
Event Date 11/18/2009
Event Type  Malfunction  
Event Description

On (b)(6) 2012 it was confirmed that the generator replacement surgery took place that day. It was stated that the surgery was a prophylactic replacement. The product is pending return for product analysis.

 
Event Description

A programming history review was performed which found no anomalies.

 
Manufacturer Narrative

Analysis of programming history.

 
Event Description

An implant card was received which confirmed that the generator replacement was prophylactic. The implant card also indicated that the lead impedance was ok and the lead was not replaced. Attempts for additional information have been unsuccessful. No additional information has been provided. The explanted generator has not been returned.

 
Manufacturer Narrative

If explanted, give date (mo/day/yr), corrected data: the initial mdr inadvertantly listed an explant date for the lead; however the lead has not been explanted.

 
Event Description

Clinic notes dated november 13, 2012 note that the patient has high lead impedance. This was found through diagnostic results that showed a dcdc code of 4. In addition, it was noted that the patient experienced voice hoarseness with stimulation, pain on the left side of the face and jaw, pain in the throat and teeth, and coughing with stimulation. The patient was scheduled for surgery on (b)(6) 2012. Good faith attempts are underway for further details about the reported events.

 
Manufacturer Narrative

Device failure suspected, but did not lead to a death.

 
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Brand NameLEAD MODEL 303
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2880622
Report Number1644487-2012-03411
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 11/20/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/19/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2009
Device MODEL Number303-20
Device LOT Number200296
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/29/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/31/2006
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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