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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 01/26/2012
Event Type  Malfunction  
Event Description

It was reported by a company representative that high impedance was reported at a follow-up appointment. X-rays were performed and the surgeon was able to see a lead discontinuity. The last known good system diagnostics were from (b)(6) 2011. No patient manipulation or trauma was reported to have contributed to the reported high impedance. X-rays were received and evaluated by the manufacturer. Review of x-rays indicated the generator was visualized in the left upper chest. The filter feed-through wires appeared to be intact. The lead connector pin seemed not to be fully inserted into the generator connector block. There is part of the lead placed behind the generator and could therefore not be assessed. Electrodes seemed correctly aligned on the vagus nerve. A lead discontinuity was visible on the lead body in the neck area. At the moment revision surgery is likely.

 
Event Description

On (b)(6) 2012, the explanted lead was received by the manufacturer for product analysis. Product analysis was completed on (b)(6) 2012. The connector pin / boot section with model and serial number tag and electrodes were not returned; therefore it was not possible to verify the model and serial number during this analysis. During the visual analysis quadfilar coil 1 appeared to be broken approximately 277mm and 285mm from the end of the cut outer / inner silicone tubes. Scanning electron microscopy was performed on quadfilar coil 1 coil break (found at 277mm) and identified the area as having evidence of a stress induced fracture with mechanical damage, residual material and no pitting. Determination could not conclusively be made on the fracture mechanism. Scanning electron microscopy was performed on quadfilar coil 1 coil break (found at 285mm) and identified the area on two of the quadfilar coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. Determination could not conclusively be made on the fracture mechanism of the remaining quadfilar coil strands. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus and calcium. It is unknown if the breaks occurred while stimulation was present due to the absence of metal pitting on the broken coil wire surfaces. What appeared to be remnants of dried body fluids were observed inside one of the inner silicone tubes, in some areas. 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. Continuity checks of the returned lead portion were performed, during the visual analysis, and no other discontinuities were identified.

 
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

Additional information was received on (b)(6) 2012 when it was discovered that the vns patient underwent a full revision surgery on (b)(6) 2012. The lead was replaced due to high impedance noticed on (b)(6) 2012. Prior to surgery, x-rays showed that the lead was fractured. There has not been any accident or trauma which could have caused the breakage. It was also reported that only the lead will be returned for product analysis, as the generator was disposed of by the hospital. The lead impedance after the new vns system was implanted was noted to be "ok". Attempts have been made for the return of the lead however it has not been received for product analysis to date.

 
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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 Key2603919
Report Number1644487-2012-01450
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/14/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/07/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2011
Device MODEL Number302-20
Device LOT Number1994
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/15/2012
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received10/15/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/01/2008
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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