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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 02/07/2014
Event Type  Malfunction  
Event Description

Additional information was received indicating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014. Multiple diagnostics showed high impedance prior to surgery. During the procedure, the surgeon re-inserted the lead pin into the generator header but the high impedance was not resolved. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.

 
Event Description

Clinic notes were received indicating that the vns patient¿s device was programmed off due to high lead impedance on (b)(6) 2014. The notes also indicate that magnet mode stimulation no longer helps shorten the patient¿s seizures. X-rays were taken and were reported by the neurologist to be unremarkable. The patient¿s device was tested again on (b)(6) 2014 and diagnostic results showed high lead impedance (impedance value ¿ 9712 ohms). The patient reported an increase in seizures since his device was programmed off. No known interventions have occurred to date.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests 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 death or serious injury.

 
Event Description

Analysis of the returned generator and lead was completed. There were no performance or any other type of adverse conditions found with the pulse generator. Monitoring of the device output signal showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current. Magnet activations performed during output monitoring demonstrate the appropriate magnet output for the programmed settings. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. During the visual analysis of the returned lead portion, the (-) connector pin quadfilar coil appeared to be broken approximately 22mm from the electrode bifurcation. Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type with mechanical damage. Pitting was observed on the coil surface. The (+) connector ring quadfilar coil appeared to be broken approximately 26mm from the electrode bifurcation. Scanning electron microscopy was performed and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting on some of the quadfilar coil breaks. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity. 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 at one time. Additional setscrew marks found on the 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, and no other discontinuities were identified. Based on the findings, there is evidence to suggest discontinuities in the returned portion of the device which may have contributed to the reported high impedance. 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.

 
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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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3784283
Report Number1644487-2014-01149
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/09/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/01/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2013
Device MODEL Number302-20
Device LOT Number201132
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/09/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received07/01/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/19/2009
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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