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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. BIPOLAR LEAD MODEL 300 Back to Search Results
Model Number 300-20
Event Date 09/10/2012
Event Type  Malfunction  
Event Description

The patient's neurologist reported that high lead impedance was found on the patient's system and normal diagnostic tests. Ap and lateral x-rays of the chest and neck were taken on (b)(6) 2012 and sent to the company for review. The generator was seen in the left chest. The filter feedthru wires were intact and the lead pins could be seen past the connector blocks indicating that they were fully inserted into the generator. A portion of the lead appeared to be located behind the generator and could not be assessed. There appeared to be a suspect area located in the coiled lead near the generator. It was possible that a break occurred in this area; however, due to the contrast and image quality of the x-rays provided, a break could not be confirmed. The electrodes were observed in the neck, but they did not appear to be aligned. In the images provided it does not appear that the anchor tether is on the nerve. The lead was seen routed down towards the generator and the lead wires appear intact at the connector pins. Based on the x-ray images provided, the cause of the high impedance cannot be determined. However, the suspect area identified in the lead or the improperly aligned electrodes may be contributing factors. The presence of micro-fractures in the lead or fractures in the portion of the lead that could not be assessed cannot be ruled out.

 
Event Description

A review of programming history, available in house revealed that during initial implant, two system diagnostic tests were run; the first resulting in high impedance while the second resulted in a dc/dc code of 0. It is unclear at this time if a lead fracture was present at the time of implant. Additionally programming history was provided by the physician who indicated that on (b)(6) 2012, prior to the generator replacement, the diagnostics showed a dc/dc of 0 on a system test and a dc/dc 1 on a normal mode test. On (b)(6) 2012 the impedance was a dc/dc equal to 7. It was noted by the physician that no trauma has been reported.

 
Event Description

It was reported that the patient was scheduled for surgical consult. Surgery is likely, but has not occurred to date.

 
Event Description

The patient's device was programmed off on (b)(6) 2014. No known surgical interventions have been performed to date.

 
Event Description

It was reported that the patient will not undergo lead replacement. It was reported that the decision to lead the vns off was made. It is believed that the patient may not be a good candidate for lead replacement surgery. No additional relevant information has been received to date.

 
Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device. Review of x-rays by manufacturer revealed a suspected lead break; however, due to the image quality and lack of contrast, this could not be confirmed. Device failure suspected to have occured, but cannot be confirmed due to image quality and lack of contrast. Suspected device failure did not cause or contribute to a death or suspected injury.

 
Manufacturer Narrative

Analysis of programming history.

 
Manufacturer Narrative

Date received by manufacturer; corrected data: the information reported on supplemental mfr. Report #3 should have been (b)(4) 2013 rather than (b)(4) 2013.

 
Event Description

Further follow-up revealed that the patient met with the surgeon and they are worried about how the patient will tolerate surgery. For this reason, the surgery has been placed on hold for now. The patient's family believes that the magnet does shorten and stop the patient's seizures.

 
Event Description

Attempts for additional information from the treating neurologist have been unsuccessful to date. While revision is likely it has not occurred to date as per the surgeon, the decision for replacement has been left up to the patient's parents.

 
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Brand NameBIPOLAR 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 Key2777500
Report Number1644487-2012-02542
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 09/10/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/09/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2003
Device MODEL Number300-20
Device LOT Number4758
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/23/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/07/2001
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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