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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

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CYBERONICS, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Event Date 12/16/2013
Event Type  Malfunction  
Event Description

It was reported that device diagnostics resulted in high impedance. It was reported that during implant surgery in (b)(6) 2012 a lot of scar tissue was noted. The patient underwent lead replacement. During the surgery the device was interrogated and high impedance was obtained. The lead pin was removed from the generator and then reinserted. System diagnostics again resulted in high impedance. It was reported that the lead was replaced. It was found that the lead was fractured at the bifurcation. The generator was left programmed off after the surgery. The lead was returned to manufacturer for analysis. Analysis is underway, but has not been completed to date. Attempts to obtain additional information have been unsuccessful to date.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

 
Event Description

It was reported that the device was not programmed off after observing the high impedance. No known patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. Analysis of the lead was completed on (b)(4) 2014. A break was identified in the negative coil. Scanning electron microscopy images of the negative coil broken ends show that pitting or electro-etching conditions have occurred at the break location. Due to metal dissolution the fracture mechanism cannot be determined. Also, images performed at the vicinity of the discolored region show that pitting or electro-etching conditions have occurred at the discolored area. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.

 
Manufacturer Narrative

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

 
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Brand NameLEAD MODEL 304
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3643548
Report Number1644487-2014-00517
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/27/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/24/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2015
Device MODEL Number304-20
Device LOT Number201709
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/11/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/24/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/10/2011
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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