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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 11/23/2011
Event Type  Malfunction  
Event Description

It was reported to our country representative in france that there was a vns patient with high lead impedance on a system diagnostic test, dcdc 7. No trauma previously reported and surgery will be planned. X-rays received for review. The generator is placed in a normal position in the upper left chest. The filter feed-through wires appeared to be intact. The lead connector pins appeared to be fully inserted. The lead wires at the connector pin appeared to be intact. The electrodes appeared to be broken and not fully attached to the vagus nerve. No strain relief-loop or bend was viewed. No tie-down was viewed either. Per labeling, a strain relief bend should be placed starting 3cm from the anchor tether and should be secured with a tie-down parallel to the anchor tether. A large loop should then be formed and secured with an additional tie-down to allow for full neck movement in all directions. Portions of the lead appeared to be behind the generator and could not be fully assessed. No acute angles or lead breaks were found. The lead body follows a straight line below the electrodes and then appears to be wound in loops around the placement of the generator. Based on the x-rays images, the reported high impedance is caused by the broken/detached electrodes.

 
Event Description

Additional information was received that diagnostics in (b)(6) 2011 were within normal limits. No manipulation of the vns system by the patient is suspected. No surgery is planned.

 
Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer and a lead discontinuities was visualized. Device malfunction suspected, but did not cause or contribute to a death or serious injury.

 
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Brand NameBIPOL LEAD MODEL 300
Type of DeviceBIPOL LEAD MODEL 300
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 Key2858611
Report Number1644487-2012-03214
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/09/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/05/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2001
Device MODEL Number300-20
Device LOT Number24865C
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/10/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/08/1999
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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