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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 07/25/2014
Event Type  Malfunction  
Event Description

The patient underwent generator and lead replacement. It was noted that an obvious break was seen near the clavicle. Device diagnostics with the new generator and lead were within normal limits. The explanted devices are expected to be returned for analysis, but have not been received to date.

 
Event Description

The explanted products were received for analysis. However, the analysis has not been completed to date.

 
Event Description

It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and diagnostic results revealed high impedance (dc dc ¿ 7). The patient¿s device was subsequently disabled. X-rays were taken and the x-ray report stated that there may be a small break caudal to the inferior edge of the left clavicle. X-rays dated (b)(6) 2014 were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block. The electrodes appeared to be placed in normal arrangement. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. A suspect area or small break in the lead appeared to be present right below the left clavicle. Based on the images provided along with the x-ray report, the cause of the high lead impedance may be due to the previously mentioned suspect area/small break. No known surgical interventions have occurred to date.

 
Event Description

Analysis was completed on the explanted devices. The generator performed according to functional specifications. During the product analysis, there were no anomalies found with the pulse generator. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The abraded opening, incision and slice marks found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process and the slice mark observed on one of the inner silicone tubes. 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, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest discontinuities in the returned portions of the device which may have contributed to the reported high lead impedance.

 
Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, suspect area visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.

 
Manufacturer Narrative

Only a portion of the lead was returned for analysis which did not reveal anomalies associated with the high lead impedance. Device failure is suspected in teh lead portion not returned, but did not cause or contribute to a death or serious injury.

 
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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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key4006855
Report Number1644487-2014-02017
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 07/25/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/13/2014
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 Number1596
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/05/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/28/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/28/2000
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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