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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 07/30/2012
Event Type  Malfunction  
Event Description

On (b)(6) 2012, it was reported that the vns patient had a full revision surgery on (b)(6) 2012, due to "spasms. " the surgeon later stated that the spasms were laryngospasms as well as choking. The patient's nurse practitioner later reported that the reason for surgery was in fact not "spasms" but a lead fracture. The patient did not have "spasms" prior to surgery. The generator was replaced for prophylactic reasons and the lead due to a lead fracture. The nurse stated that the lead was discarded after surgery and therefore, would not be sent back for product analysis but the generator would be sent back. The generator has not yet been received by the manufacturer for product analysis. The manufacturer's consultant stated that the high impedance was observed prior to surgery, upon interrogation during a clinical visit. There was no trauma or patient manipulation that occurred which could have caused or contributed to the high impedance. Attempts for further information have been made but have been unsuccessful.

 
Event Description

Additional information was received on (b)(6) 2012, when the explanted generator was returned for product analysis but that the lead had been discarded by the hospital. It was later reported that the high impedance was first observed on (b)(6) 2012. Product analysis on the explanted generator was completed on (b)(6) 2012. The generator had been replaced for prophylactic reasons. The data in the memory locations revealed that 72. 275% of the battery had been consumed and the battery had a voltage left of 2. 837v. The results of bench diagnostic testing indicated the device was operating properly. Electrical test results showed that the pulse generator performed according to functional specifications and there were no performance or any other type of adverse conditions found with the pulse generator.

 
Event Description

Additional information was received on (b)(4) 2012 when product analysis was completed on the explanted lead. A small portion of the (+) white electrode quadfilar coil 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 29mm portion the end of the (+) white electrode quadfilar coil appeared to be burnt. Scanning electron microscopy was performed and identified the burnt area as having the appearance of being melted, with re-solidified material (evidence of being melted at one time). What appeared to be spatter was found on the surface of the quadfilar coil strands. It is unknown exactly what caused the quadfilar coil to melt. Based on the obvious signs of mechanical damage on the coil surfaces, it is possible the thermally-damaged coils were exposed to a high temperature device such as a cauterizing tool (electrosurgical unit) during the explant of this lead. However, based on the observed mechanical and thermal damage to the coil ends, it cannot be determined whether the discontinuities are explant or product related. During the visual analysis of the returned 29mm portion the (-) green electrode quadfilar coil appeared to be broken at the proximal 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 with pitting. Pitting was 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 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 except for the set of setscrew marks found at 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 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, with no other discontinuities identified.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

Date of event; corrected data: additional information was received which changes the event date that was reported on the initial report.

 
Manufacturer Narrative

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

 
Event Description

Product analysis on the generator also showed that on (b)(6) 2012, the impedance value went from 11986 ohms to 20446 ohms, both of which are high impedance values.

 
Manufacturer Narrative

Describe event or problem; corrected data: inadvertently did not include this information on supplemental report #1.

 
Event Description

Additional information was received on (b)(6) 2012, when it was reported that on (b)(6) 2012, the lead had been fully explanted, as it was reported that the patient had his vns explanted previously on (b)(6) 2012, it appears that only a portion of the lead had previously been explanted and the rest of the lead was explanted on (b)(6) 2012. The lead was reported to have been discarded by the hospital and therefore could not be returned for product analysis. The explanted lead however was returned for product analysis on (b)(6) 2012. Product analysis is still underway and has not yet been completed.

 
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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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2715100
Report Number1644487-2012-02143
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 08/02/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/27/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2011
Device MODEL Number302-20
Device LOT Number2143
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/28/2012
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/17/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/17/2008
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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