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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. BIPOL LEAD MODEL 300 Back to Search Results
Model Number 300-20
Event Date 04/19/2012
Event Type  Malfunction  
Event Description

Ap chest, lateral chest, and ap neck x-ray images were received on (b)(6) 2012. The generator is visible in the upper, left chest. The generator is placed normally. The connector pins appear to be fully inserted inside the connector blocks. The feedthru wires appear intact. Lead is present behind the generator and cannot be assessed for continuity. No sharp angles are present. Lead wires appear intact at the connector pins. There is a suspect area of continuity in the lead body. A gross lead discontinuity is suspected at the bottom of the strain relief bend. Based on the x-rays images received there appears to be a suspected lead discontinuity. As the entire lead could not be assessed, continuity in the obstructed portion of the lead cannot be confirmed. On (b)(6) 2012, the patient underwent lead and generator explant due to high impedance and a dead battery. The explanted devices were received on (b)(6) 2012. Product analysis for the explanted lead showed that a portion of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The abraded opening 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. 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. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No 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 portions were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device which may have contributed to the stated complaints. Note that since a portion of the lead assembly (body) including 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 review x-rays of implanted device. Review of x-rays by the manufacturer revealed a gross lead discontinuity. Only a portion of lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned but did not cause or contribute to a death or serious injury.

 
Event Description

A fax was received from the physician on (b)(6) 2012. It is unknown if patient manipulation or trauma occurred that caused or contributed to the event. A product malfunction was indicated. The physician also noted that the patient's device was an older model and would be replaced with a newer model when the lead is replaced. It was also indicated that the patient had not yet undergone surgery has the patient had not kept an appointment with the surgeon. Surgery is still likely but has not taken place to date.

 
Event Description

On (b)(6) 2012, a physician reported high impedance readings from systems diagnostics performed on (b)(6) 2012 for a vns patient. The patient did have any serious falls and has not experienced any increase in seizures. X-rays were taken; however, the physician could not see a lead break in the area of the chest that was imaged. Additional x-rays were scheduled; however, it is unclear if they were actually taken. No images were provided for manufacturer review. A battery life calculation was performed with results of 1. 28 years until eri to yes. Surgery is likely but has not taken place to date.

 
Manufacturer Narrative

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

 
Event Description

Pa for the generator was approved on (b)(4) 2012. During the analysis, there was no indication from the device that an end of service condition existed. The device performed according to functional specifications. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found.

 
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Brand NameBIPOL LEAD 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 Key2581839
Report Number1644487-2012-01262
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 04/23/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/21/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2002
Device MODEL Number300-20
Device LOT Number1671
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/05/2012
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/06/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/09/2000
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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