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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 10/22/2014
Event Type  Malfunction  
Event Description

There is no plan for vns re-implant at this time. Although re-implant may occur in the future, it has not occurred to date.

 
Event Description

It was initially reported that the patient had generator and lead explant on (b)(6) 2014 due to an unknown reason. The explanted devices were returned to the manufacturer for analysis. The generator showed that the device was at end of service condition as result of expected normal battery depletion. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. Analysis of the returned lead portion was completed on (b)(6) 2014. Note that the lead assembly (body) including the section of the connector boot containing the model and serial number tag and the electrode section was not returned; therefore it was not possible to verify the model and serial number during this analysis and a complete evaluation could not be performed on the entire lead product. During the visual analysis, the (-) connector pin quadfilar coil appeared to be stretched and kinked and extended approximately 3mm past the end of the connector ring. Two strands of the (+) connector ring quadfilar coil appeared to be stretched and kinked and extended approximately 1mm past the end of the connector ring. Determination could not be made as to whether the ends of the quadfilar coils were broken. Scanning electron microscopy was performed on the (-) connector pin quadfilar coil break (found at 3mm) and identified the area on three of the broken coil strands as being mechanically damaged which prevented identification of the coil fracture type, no pitting and evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture. The remaining broken coil strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, no pitting and a secondary break line. Scanning electron microscopy was performed on the two coil strands of the (+) connector ring quadfilar coil break (found at 1mm) and identified the areas as having extensive pitting which prevented identification of the coil fracture type. The area on one of the remaining two broken coil strands found inside the connector ring area was identified as being mechanically damaged which prevented identification of the coil fracture type and no pitting. The remaining broken coil strand found inside the connector ring area was identified 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. With the exception of the observed discontinuities the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted except for the half set of setscrew marks observed on the connector pin, indicating the connector pin had not been fully inserted into the cavity of the pulse generator at one time. The observed location of the canted spring marks suggests there may have been intermittent contact with 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. Based on the findings in the product analysis lab, there is evidence of discontinuities in the returned portion of the device. Note that since the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. The surgeon¿s office reported that the patient was referred for generator replacement surgery due to end of service, but during surgery, the surgeon found that there were ¿fractured electrodes. ¿ as a result, they did not move forward with replacement of the system because the patient had not consented for lead replacement. Although re-implant may occur in the future, it has not occurred to date.

 
Manufacturer Narrative

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

 
Event Description

It was reported that the patient was implanted. No additional relevant information has been reported.

 
Event Description

Clarification was received from the currently treating physician that a note dated (b)(6) 2014 from the treating physician at that time reports that his vns was explanted, and the fractured lead previously mentioned in (b)(6) 2016 was in reference to the remaining lead not explanted. Any additional information regarding re-implant is not relevant to this report. No additional relevant information has been received to date.

 
Event Description

An implant card was received indicating that the patient under vns re-implantation surgery. The implant card had a notation stating the removal of the old lead occurred. This was determined to be in reference to the remaining lead not explanted as previously noted in this report. Attempts at product return revealed that pathology in the facility did not receive any explanted products for the patient. The recently explanted portion of the lead has not been received by the manufacturer to date. Any additional information regarding re-implant is not relevant to this report.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
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 Key4372198
Report Number1644487-2014-03481
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup
Report Date 11/30/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/30/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2007
Device MODEL Number302-20
Device LOT Number011863
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/07/2014
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/10/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/02/2005
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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