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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 300

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CYBERONICS, INC. LEAD MODEL 300 Back to Search Results
Model Number 300-20
Event Date 01/14/2013
Event Type  Malfunction  
Event Description

It was initially reported that the patient had high impedance. The patient was sent for x-rays but they had not been provided to the manufacturer for review. The patient had their output current turned down to 0. 5 ma and the physician does no plan to turn the patient off. The patient also reported that he was experiencing a shocking sensation at the same appointment where the high impedance was discovered. The patient has a generator and lead replacement and the explanted products were returned to the manufacturer for evaluation. Product analysis is planned but has not been complete.

 
Event Description

Additional information was received that the product analysis was completed on the lead. Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis the (+) marked quadfilar coil appeared to be broken approximately 69mm and 73mm from the connector bifurcation and at approximately 10mm from the electrode bifurcation with three broken coil strands at approximately 9mm. Scanning electron microscopy was performed on the (+) marked connector quadfilar coil breaks (found at 69mm and 73mm) and identified the areas as having extensive pitting which prevented identification of the coil fracture type. Scanning electron microscopy was performed on the (+) marked connector quadfilar coil break (found at 10mm) and identified the area as being mechanically damaged which prevented identification of the coil fracture type with fine pitting. The area on the three broken coil strands was identified as being mechanically damaged. 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. The abraded openings found on the outer and inner silicone tubes, most likely provided the leakage path for what appeared to be remnants of dried 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 and calcium. Refer to attached eds sheet for additional information. 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. 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 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 electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

 
Manufacturer Narrative

 
Manufacturer Narrative

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

 
Event Description

Additional information was received that there was no reported manipulation or trauma. X-rays will not be sent to the manufacturer for review. On diagnostics the dcdc code was 7. Product analysis was completed on the generator but has not been completed on the lead. The generator performed according to functional specifications. During product analysis there were no anomalies found with the pulse generator.

 
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Brand NameLEAD MODEL 300
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 Key2955719
Report Number1644487-2013-00366
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/14/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/11/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2004
Device MODEL Number300-20
Device LOT Number5692
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/11/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/18/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/02/2002
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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