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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
Event Date 02/29/2012
Event Type  Malfunction  
Event Description

Additional information was received on (b)(6) 2012, when the nurse reported that the patient doesn't speak, but communicates by pointing at pictures; sometimes when the vns stimulates the patient will make a sound that sounds like "hoarseness". This has not occurred since (b)(6) 2011. The nurse stated that she does not know the relationship of the hoarseness to vns. System diagnostics were performed on (b)(6) 2011, which showed dcdc of 2 and then on (b)(6) 2012, system diagnostics showed high impedance with dcdc=7. Therefore x-rays were ordered. No patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. The generator has been disabled due to the high impedance. Although surgery is likely, it has not occurred to date.

 
Event Description

On (b)(6) 2012 a vns treating nurse reported that the vns patient has high impedance with a dcdc of 7. The care giver noticed that the patient's hoarseness was gone. It was reported that x-rays were taken with a potential lead breakage and that they would be sent to the manufacturer for review. The battery was stated to be ok and the patient's settings are output=1. 75ma/pulse width=500usec/frequency=30hz/on time=30sec/off time=3min/magnet output=3ma/magnet on time=30sec. X-rays were received and reviewed by the manufacturer. The lead connector pin appeared to be fully inserted into the generator connector block. Part of lead is placed behind the generator and could not be assessed. No obvious lead discontinuity found on part of the lead that could be assessed. Due to the quality of the images, part of the lead close to the electrodes cannot be fully assessed. Based on the x-ray images, the cause of the reported high impedance cannot be identified.

 
Event Description

On (b)(6) 2012, the programming history was reviewed. A battery life calculation was performed which showed 1. 03 years remaining until neos=yes.

 
Manufacturer Narrative

Date of event; corrected data: additional information was received which changes the event date.

 
Manufacturer Narrative

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

 
Event Description

On (b)(6) 2013, the manufacturing records for the lead were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.

 
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Brand NameLEAD MODEL 302
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 Key2666564
Report Number1644487-2012-01856
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 06/25/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/24/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2009
Device MODEL Number302-20
Device LOT Number1732
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received06/26/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/13/2006
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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