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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 303

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CYBERONICS, INC. LEAD MODEL 303 Back to Search Results
Model Number 303-20
Event Date 10/29/2014
Event Type  Malfunction  
Event Description

It was reported that the patient was supposed to undergo generator replacement due to end of service on (b)(6) 2014 but pre-operative diagnostics showed high impedance. The surgery was therefore cancelled for the day. Although surgery is likely, it has not occurred to date.

 
Manufacturer Narrative

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

 
Event Description

On (b)(6) 2014 the explanted generator and lead were returned for product analysis. Product analysis is still underway and has not yet been completed.

 
Manufacturer Narrative

(b)(4).

 
Event Description

Product analysis was completed on the lead on (b)(6) 2014. The (+) white and (-) green electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 125mm portion the end of the (-) green electrode tri-filar coil appeared to be broken approximately 15mm from the distal end of the anchor tether. Scanning electron microscopy was performed and identified the area as being mechanically damaged which prevented identification of the coil fracture type. Fine pitting was observed on two of the broken coil strands. Evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture was observed on the remaining broken coil strand. Pitting and flat spots were observed on the coil surface. 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. With the exception of the observed discontinuity 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 pin 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. Product analysis was completed on the generator on 12/22/2014. An end-of-service warning message was verified in the pa lab. With the pulse generator case removed and the battery still attached to the pcb, the battery measured 1. 971 volts, indicating an eos condition. The data from the generator shows an increase of impedance to 9434 ohms, which occurred on (b)(6) 2014. There were no performance or any other type of adverse conditions found with the pulse generator.

 
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Brand NameLEAD MODEL 303
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 Key4264382
Report Number1644487-2014-03086
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 10/29/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/20/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/30/2013
Device MODEL Number303-20
Device LOT Number200350
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/03/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/18/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/31/2006
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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