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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 04/21/2012
Event Type  Malfunction  
Event Description

Good faith attempts were made and no further information was attained.

 
Manufacturer Narrative

Type of report corrected data; omitted on initial report, 30 day report.

 
Event Description

Additional information was received that the patient's device was disabled (b)(6) 2012. The patient after their device was disabled started to have increased seizures with the loss of therapy. The patient now wants to have full revision surgery. No surgery date planned at this time as the patient has broken ribs that need to heal first.

 
Event Description

It was reported that the patient underwent generator and lead replacement surgery on (b)(6) 2013. The generator and lead were returned to manufacturer for analysis on (b)(4) 2013. Analysis of the lead was completed on (b)(4) 2013. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis the (+) marked connector quadfilar coil appeared to be broken approximately 246mm and 248mm from the connector boot. Scanning electron microscopy was performed on the (+) marked connector quadfilar coil break (found at 246mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type with mechanical damage and residual material. Scanning electron microscopy was performed on the (+) marked connector quadfilar coil break (found at 248mm) and identified the area as having flat spots on the coil surface with pitting and mechanical damage. Evidence of a stress induced fracture was observed, but determination could not conclusively be made on the fracture mechanism. 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. The abraded openings found on the outer and inner silicone tubes, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer and inner silicone tubes. 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, phosphorus, sodium, magnesium, zirconium, sulphur and calcium. With the exception of the observed discontinuity, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other 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 portion were performed, during the visual analysis, and no other discontinuities were identified. The abraded openings observed on the outer and inner silicone tubes have the potential for contributing to the painful stimulation allegation. Analysis of the generator was completed on (b)(4) 2013. Although the septa were cored, but no bodily fluid remnants were observed in the header septa cavities, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery shows a non-ifi condition. There were no performance or any other type of adverse conditions found with the pulse generator.

 
Manufacturer Narrative

New information received identified the date of event. Device failure occurred, but did not cause or contribute to a death or serious injury.

 
Event Description

Neurology reported that they had a vns patient with high lead impedance. A system diagnostic test resulted in 8393 ohms/limit/high. The patient had their generator replaced on (b)(6) 2012 and no diagnostics have been performed since that date. It is unknown if the patient experienced any trauma to the site. The patient did start to experience pain at the generator site a few days prior to this clinic visit when their vns activated. The site is aware to program their vns off. It is unknown if this has been done. The patient at this time has no surgery planned because they are seizure free. X-rays were received for review. Lateral neck and ap chest x-rays via disc and were reviewed. The generator is visualized in the left upper chest in a normal orientation. Filter feedthru wires appear to be intact and the lead pins appear to be fully inserted into the header of the generator. The lead body is intact at the lead pins. The lead body and electrode site were able to be visualized. The electrodes appeared to be possibly not be in alignment. It is possible the anchor tether is displaced, but cannot be visualized. There is lead behind the generator that cannot be assessed. A strain relief bend is present but not per labeling. The strain relief loop does not appear to be adequate. One tie-down is present but is within the loop. Most of the lead was visible and no obvious lead discontinuities or anomalies were identified. Some lead is behind the generator and this portion cannot be assessed. Based on the x-ray review, no obvious lead discontinuities or anomalies were observed in the x-ray images that may be contributing to the allegation of high lead impedance. It is possible there is an issue with the lead behind the generator that cannot be visualized or a lead break that cannot be seen on x-ray. Good faith attempts are underway for further information.

 
Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuity 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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2585284
Report Number1644487-2012-01291
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 04/30/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/23/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2000
Device MODEL Number300-20
Device LOT Number10741C
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/24/2013
Is The Reporter A Health Professional? Yes
Distributor Facility Aware Date07/17/2012
Event Location Other
Date Manufacturer Received09/19/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/30/1998
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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