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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 302-30
Event Date 05/15/2014
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
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 diagnostic results revealed high lead impedance (impedance value >= 10,000 ohms). Troubleshooting was performed multiple times including lead pin re-insertion. The patient¿s lead was replaced during the procedure. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2008.

 
Manufacturer Narrative

Review of the available programming and diagnostic history. Device failure is suspected, but did not cause or contribute to a death or serious injury.

 
Event Description

Additional information was received stating that no trauma was reported prior to the high impedance observation. Analysis of the returned generator and lead was completed. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the generator. The end of service condition of the returned generator was determined to be the result of normal battery depletion. The depletion was an expected event as determined by blc and battery voltage measurement. The module performed according to functional specifications. During the visual analysis of the returned lead portion, quadfilar coil 1 appeared to be broken approximately 86mm from the end of the abraded open / cut outer silicone tubing. Scanning electron microscopy was performed and identified the area on two of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. The areas on the remaining broken coil strands were identified as being mechanically damaged which prevented identification of the coil fracture type and no pitting. Pitting was observed on the coil surface. Quadfilar coil 1 also appeared to be broken approximately 172mm from the end of the abraded open / cut outer silicone tubing. Scanning electron microscopy was performed 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 no pitting. The areas on the remaining broken quadfilar coil strands were identified as having extensive pitting which prevented identification of the coil fracture type. Pitting was observed on the coil surface. Quadfilar coil 2 appeared to be broken approximately 122mm from the end of the abraded open / cut outer silicone tubing. Scanning electron microscopy was performed and identified the area on three of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. The area on the remaining broken quadfilar coil strand was identified as being mechanically damaged which prevented identification of the coil fracture type and no pitting. Quadfilar coil 2 also appeared to broken at approximately 171mm from the end of the abraded open / cut outer silicone tubing. Scanning electron microscopy was performed and identified the area as being mechanically damaged which prevented identification of the coil fracture type and no pitting. Determination could not conclusively be made on the fracture mechanism. 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. The abraded openings found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. For the observed inner tubing fluid remnants, 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 discontinuities, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator. The additional 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 and no other discontinuities were identified. Based on the findings, there is evidence to suggest discontinuities in the returned portions of the device which may have contributed to the reported high impedance. Note that since the (+) white and (-) green electrodes were not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

 
Manufacturer Narrative

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

 
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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 Key3864123
Report Number1644487-2014-01455
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/15/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/10/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2006
Device MODEL Number302-30
Device LOT Number11608
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/05/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/29/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/08/2004
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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