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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 05/30/2013
Event Type  Malfunction  
Event Description

Additional information was received that the patient had a generator and lead replaced. Product analysis was completed on the lead and generator. Generator performed according to functional specifications in the pa lab; signs of discoloration and slight header delamination appear to be related to post-explant environmental exposure. Results of diagnostic testing indicated the device was operating properly. Electrical test showed that the pulse generator was operating within specification. Other than the observed condition of the header there were no adverse functional, mechanical, or visual issues identified with the returned generator. Confirmed discontinuity of negative quadfilar coil in both the body and electrode regions of the returned lead portion; also observed abraded openings of both outer and inner tubing near the break area. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis the (-) connector pin quadfilar coil appeared to be discolored and dissolved, in some areas. What appeared to be a green substance was observed inside the outer and (-) connector pin inner silicone tubing. During the visual analysis the (-) connector pin quadfilar coil appeared to be broken approximately 273 mm and 356 mm from the end of the connector boot. Scanning electron microscopy was performed on the (-) connector pin quadfilar coil break (found at 273 mm) and identified the area as being thin, having extensive pitting which prevented identification of the coil fracture type and evidence of electro-etching on the coil surface. During the visual analysis the (-) connector pin quadfilar coil appeared to be broken approximately 24 mm from the end of the cut inner silicone tubing. Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type and mechanical damage. 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 silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. The observed green substance is believed to be remnants of the dissolved (-) connector pin quadfilar coil. 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 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 electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

 
Event Description

Attempts for additional information have been unsuccessful to date.

 
Manufacturer Narrative

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

 
Event Description

The explanted vns generator and lead were received on (b)(4) 2013 and analysis is pending.

 
Event Description

A neurologist reported that he had a vns patient with high lead impedance (system ok/ok/3. 0/high/9647/no) he noted that the patient's device was implanted on (b)(6) 2011 and there have been no known causes of the high impedance. No x-rays were taken at that time. The patient had surgery (b)(6) 2013. Their generator and lead was explanted. Re-implant surgery is planned for (b)(6) 2013. It was reported that the patient had swelling in their generator pocket and fluid was noted. For this reason their device was explanted. Lead and generator explanted. Good faith attempts are underway for further details about the reported event and for product return for analysis.

 
Manufacturer Narrative

Device malfunction suspected but did not cause or contribute to a death.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD MODEL 302
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3187848
Report Number1644487-2013-01902
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 05/30/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/25/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2011
Device MODEL Number302-20
Device LOT Number2185
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/27/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received06/30/2014
Was Device Evaluated By Manufacturer? No
Date Device Manufactured09/10/2008
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/25/2013 Patient Sequence Number: 1
Treatment
EMPTY
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