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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 06/28/2013
Event Type  Malfunction  
Event Description

On (b)(4) 2013 it was reported that the patient underwent battery replacement surgery due to the generator being at end of service and upon reconnecting the lead to a new generator, high lead impedance was observed. The issue was not corrected during surgery and the patient was closed up and sent to recovery. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Operative notes from the patient¿s surgery indicated that after the high impedance was observed, the surgeon explored the lead and isolated the electrodes and found that they had actually broken as there was ¿some plastic sheathing in the pocket¿. The surgeon stated that it was very clear that this was an old phenomena and that it may have happened after the generator replacement in 2007. It was stated that there were no diagnostics from prior to the generator being at end of service as the latest neurologist who was treating the patient never performed them. No x-rays will be performed as the surgeon physically observed the lead break during surgery. The surgeon does not believe patient manipulation or trauma caused the lead break. The patient¿s generator was left disabled during surgery due to the high impedance. Although surgery is likely, it has not occurred to date.

 
Event Description

On (b)(6) 2013, an implant card was received indicating the patient had the vns lead replacement on (b)(6) 2013, due to a lead discontinuity. Product analysis of the explanted generator (from the surgery when the high impedance was initially discovered) due to end of service was performed. It was verified that the end of service condition was the result of normal battery depletion. The depletion was an expected event as determined by battery life calculation and battery voltage measurement. The module performed according to functional specifications. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. On (b)(6) 2013, both the new generator and lead were replaced. The explanted devices were returned for product analysis. Product analysis of the returned generator found that the device performed according to functional specifications. Analysis in the lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found.

 
Event Description

A break was identified in the positive and the negative lead coils. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the end of coil. Due to metal dissolution the fracture mechanism cannot be determined. Scanning electron microscopy images of the negative coil show that a stress-induced fracture (fatigue) has occurred in at least three strands of the quadfilar coil. Scanning electron microscopy images of coil 1 show that pitting or electro-etching conditions have occurred at the end of coil. However, due to pitting or metal dissolution and mechanical distortion (smoothed surfaces) the fracture mechanism cannot be determined. Scanning electron microscopy verified that secondary fractures exited in the vicinity of the broken end. However, due to mechanical distortion (smoothed surfaces) the fracture mechanism cannot be determined. Scanning electron microscopy images of coil 2 show that a stress-induced fracture (fatigue) has occurred in at least two strands of the quadfilar coil. Also, the early stages of what appears to be a secondary fracture was identified in the vicinity of the broken strands. Note that since a portion of the lead (including the lead¿s electrodes) were not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations typical wear and explant related observation, no other anomalies were identified in the returned lead portions.

 
Manufacturer Narrative

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 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 Key3239093
Report Number1644487-2013-02198
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/28/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/22/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2003
Device MODEL Number300-20
Device LOT Number4398
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/23/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/21/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/22/2001
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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