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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 11/28/2012
Event Type  Malfunction  
Event Description

Product analysis on the explanted lead was performed. Setscrew marks were observed on the connector pin. The marks provide evidence of a proper mechanical contact between conductive surfaces of both the generator and connector pin, thereby ensuring a good electrical connection to the lead. A half set of setscrew marks was found near the end of the connector pin, indicating the connector pin had not been fully inserted into the cavity of the pulse generator at one time. However, based on the location of the setscrew marks on the pin, it is unknown whether a good electrical connection was present for the connector ring. The positive connector ring inter-face backfill appeared to be partially detached. Slice marks were observed on the connector pin and connector ring inner silicone tubes, past the electrode bifurcation. The marks penetrated the insulation and some of the coil strands appeared to be cut in half, in some areas. During the visual analysis the positive connector ring quadfilar coil appeared to be broken approximately 1mm from the end of the electrode bifurcation. Scanning electron microscopy was performed on the connector end of the positive connector ring quadfilar coil break and identified the area as having extensive pitting which prevented identification of the coil fracture type with mechanical damage. Scanning electron microscopy (sem) was performed on the electrode (mating) end of the positive connector ring quadfilar coil break and identified the area as having evidence of a stress induced fracture with mechanical damage and 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 which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. With the exception of the observed discontinuity, 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 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 portion were performed, during the visual analysis, and no other discontinuities were identified. Based on the findings in the product analysis lab, there is evidence to suggest a discontinuity in the returned portion of the device. Note that since the positive white and negative green electrodes were not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Note that the (+) white and (-) green electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. No additional information has been provided.

 
Event Description

A review of the decoder data for the generator indicates that the high impedance was first observed on (b)(6) 2012 16:46.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

Event date, corrected data: initial mdr inadvertantly included the incorrect event date.

 
Event Description

On (b)(4) 2013 the nurse reported that she had just seen the patient and high impedance and a low output current were observed. It was stated that the patient recently had an injury where he fell on his back and the nurse believes this was the cause of the high impedance. The date of the injury was unknown to the nurse. The patient's device was disabled and he was sent to get x-rays taken. The nurse said that the patient was last seen on (b)(6) 2012 and interrogation showed everything was ok. The patient went in for a full revision surgery on (b)(6) 2013. Diagnostics were performed during surgery which showed the device was ok. Diagnostics were again performed after the patient's head was positioned to the right, which showed it was ok with an impedance value of 967 ohms. When diagnostics were performed with the patient's head positioned to the left, high impedance was observed with a value of 6064 ohms. Both the generator and lead were returned on (b)(4) 2013. Product analysis of the generator indicated the device was operating properly. Electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator. The lead is pending product analysis. No additional information has been provided.

 
Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a 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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2950033
Report Number1644487-2013-00326
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/10/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/08/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2011
Device MODEL Number302-20
Device LOT Number200985
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/17/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/24/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/12/2008
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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