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CYBERONICS, INC. BIPOL LEAD MODEL 300 Back to Search Results
Model Number 300-20
Event Date 11/06/2013
Event Type  Malfunction  
Event Description

It was reported that the patient underwent generator and lead replacement due to high impedance. It was reported that the generator was programmed off after observing the high impedance. It is unknown if any trauma or patient manipulation occurred that could have caused or contributed to the high impedance. X-rays were not taken. The generator and lead were received by device manufacturer for analysis on 11/21/2013. Analysis is underway, but has not been completed to date. The implant card was received and indicated that the lead was replaced due to a lead break.

Event Description

Analysis of the generator was completed on (b)(4) 2013. The device performed according to functional specification. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found. Analysis of the lead was completed on (b)(4) 2013. Note that a portion of the lead assembly (body) including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 309mm portion the unmarked connector pin quadfilar coil appeared to be broken approximately 87mm and 98mm from the connector bifurcation. Scanning electron microscopy was performed on the (-) unmarked connector pin quadfilar coil break (and identified the areas as having evidence of being worn to the point of fracture with flat spots, pitting and residual material on the coil surface. It is unknown if the breaks occurred while stimulation was present due to the absence of metal pitting on the broken coil wire surfaces. The abraded openings found on the outer 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 outer and inner silicone tubes. 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, sodium, magnesium, potassium, iron, aluminum, sulphur and calcium. 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. The setscrew marks found on the lead connector pins 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.

Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. 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.

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Type of DeviceLEAD
Manufacturer (Section D)
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
MDR Report Key3497158
Report Number1644487-2013-03666
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/06/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/03/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/29/2004
Device MODEL Number300-20
Device LOT Number5423
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/21/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/12/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/04/2002
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial