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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 07/01/2014
Event Type  Malfunction  
Event Description

It was reported that the patient was scheduled for generator and lead replacement due to either a lead break or sclerosis of nerve. It was reported that a lead break was not observed on x-rays. The patient underwent lead replacement due to high impedance and prophylactic generator replacement. The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

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

 
Event Description

Analysis of the lead was completed on (b)(4) 2014. During the visual analysis of the returned 360mm portion the (-) connector pin quadfilar coil appeared to be broken approximately 13mm and the (+) connector ring quadfilar coil appeared to be burnt at approximately 25mm past the end of the abraded open / torn outer silicone tubing. Scanning electron microscopy was performed on the (-) connector pin quadfilar coil break (found at 13mm) and identified the area on three of the quadfilar coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. The area on the fourth quadfilar coil strand was identified as being mechanically damaged which prevented identification of the coil fracture type and no pitting. Scanning electron microscopy was performed on the (+) connector ring quadfilar coil burnt area (found at 25mm) and identified the area as having the appearance of being melted, with re-solidified material (evidence of being melted at one time). What appeared to be spatter was found on the surface of the quadfilar coil strands. Pitting was observed on the coil surface. During the visual analysis of the returned 45mm portion the quadfilar coil appeared to be burnt approximately 89mm past the end of the torn inner silicone tubing. Scanning electron microscopy was performed and identified the area as having the appearance of being melted, with re-solidified material (evidence of being melted at one time). Pitting was observed on the coil surface. During the visual analysis of the returned 23mm portion the (+) white electrode quadfilar coil appeared to have a spot-weld / slug attached to the end approximately 8mm from the end of the torn inner silicone tubing. Scanning electron microscopy was performed and revealed a spot-weld / slug at the end of the coil attached to a portion of the ribbon. It is unknown if the breaks occurred while stimulation was present due to the absence of metal pitting on the broken coil wire surfaces. It is unknown exactly what caused the quadfilar coil to melt. Based on the obvious signs of mechanical damage on the coil surfaces, it is possible the thermally-damaged coils were exposed to a high temperature device such as a cauterizing tool (electrosurgical unit) during the explant of this lead. The abraded open / torn areas found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. As expected, analysis of generator resulted in no anomalies.

 
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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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3995582
Report Number1644487-2014-01982
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/14/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/08/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2006
Device MODEL Number302-20
Device LOT Number010182
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/24/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received08/25/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/03/2004
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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