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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 02/28/2014
Event Type  Malfunction  
Event Description

It was reported that the vns patient¿s device was tested and diagnostic results revealed high lead impedance (impedance value >= 10,000 ohms). The patient¿s device was not programmed off. Clinic notes were received stating that the high impedance was first observed during an office visit on (b)(6) 2014. The patient has not experienced any changes in her seizure control. The notes also indicate that the battery appeared to be depleting too quickly even with the high duty cycle. No known interventions have occurred to date. Attempts for additional relevant information were made but have been unsuccessful to date.

 
Event Description

The patient underwent generator and lead replacement on (b)(6) 2014. The lead and generator were received on (b)(4) 2014. Analysis is underway, but has not been completed to date. Attempts to obtain additional relevant information have been unsuccessful to date.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

 
Manufacturer Narrative

Device failure occurred, but did not cause or contribute to death or serious injury.

 
Event Description

Additional information was received stating that the vns patient did not have any trauma, changes in device settings, or changes in medications that may have contributed to the high impedance. The patient's device was disabled on (b)(6) 2014. The patient was doing well following replacement surgery. Analysis of the returned generator and lead was completed. Monitoring of the generator's device output signal showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current. 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. During the visual analysis of the returned 385mm lead portion, the (-) green electrode quadfilar coil appeared to be broken approximately 3mm from the electrode bifurcation. Scanning electron microscopy was performed identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and fine pitting. Pitting was observed on the coil surface. 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. During the visual analysis of the returned 385mm portion the (+) white electrode and ribbon appeared to be embedded in remnants of dried body tissue. This condition may have prevented the (+) white electrode ribbon from coming in contact with the vagus nerve. With the exception of the observed discontinuity and the tissue-covered (+) white electrode and ribbon the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. Abrasions were observed in various locations, possibly caused by wear. Coils appeared slightly stretched, kinked and wavy in some areas which most likely occurred due to manipulation of the lead during the explant process. 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 other discontinuities identified. Based on the findings, there is evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the high impedance. However, the positive electrode condition may have contributed to the reported high impedance.

 
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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 Key3710150
Report Number1644487-2014-00818
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/01/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/28/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2000
Device MODEL Number300-20
Device LOT Number12932C
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/15/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received05/20/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/25/1998
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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