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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 07/08/2014
Event Type  Malfunction  
Event Description

It was reported that during generator replacement surgery on (b)(6) 2014 due to end of service, the vns patient¿s replacement generator was tested with the existing lead and system diagnostic results revealed high impedance (dc dc ¿ 7). The lead pin was reinserted into the generator header but the high impedance did not resolve. The replacement generator was tested with a test resistor and lead impedance was within normal limits. The surgeon elected to replace the patient¿s lead during the procedure. The explanted generator and lead were returned to the manufacturer where analysis is currently underway.

 
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 to a death or serious injury.

 
Event Description

Analysis of the lead was completed on (b)(4) 2014. Note that portions of the (+) white and (-) green electrode inner silicone tubes and quadfilar coils and anchor tether (with exception of a piece of helical) were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 292mm portion the (+) connector ring quadfilar coil appeared to be broken approximately 157mm and 168mm from the end of the connector boot. Scanning electron microscopy was performed on the (+) connector ring quadfilar coil break (found at 157mm) and identified the area on one of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and pitting. The area on the remaining broken coil strands was identified as being mechanically damaged with pitting which prevented identification of the coil fracture type. Pitting was observed on the coil surface. Scanning electron microscopy was performed on the (+) connector ring quadfilar coil break (found at 168mm) and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded openings and slice mark 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 found inside the outer silicone tubing. The slice mark found on one of the and inner silicone tubes 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 found inside the inner silicone tubing. For the observed inner tubing fluid remnants found inside the remaining inner silicone tubing, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. With the exception of the observed discontinuity the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. Analysis of the generator was completed on (b)(4) 2014. The module performed according to functional specifications. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device.

 
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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 Key4051164
Report Number1644487-2014-02137
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/04/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/02/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2008
Device MODEL Number302-20
Device LOT Number1300
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/21/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/10/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/20/2005
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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