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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-30
Event Date 01/31/2013
Event Type  Malfunction  
Event Description

A vns treating vns neurologist reported that high lead impedance was observed on both system and normal mode diagnostics (dcdc=7) performed of the patient's model 102 generator. There was no known trauma or manipulation noted that may have contributed to the event. The patient was seen on (b)(6) 2013, to have her device turned back on following it being turned off for an mri procedure. It is unknown to date if diagnostics were performed prior to the mri as recommended in manufacturer precautions. The neurologist believes in his opinion that the low battery may be causing the high impedance on the systems diagnostic test. It is unknown to date if the patient's device was turned off as recommended in manufacturer labeling. The patient is being referred for generator and lead replacement surgery. Attempts for additional information have been unsuccessful to date.

 
Event Description

It was reported that the patient was scheduled for generator and lead replacement on (b)(6) 2013 which occurred as scheduled. The device was not turned off prior to surgery and was set to 2. 0ma. The patient confirmed that she was not experiencing any side effects such as painful stimulation or any abnormal effects. An x-ray was performed sometime prior to surgery, but the x-rays will not be provided to manufacturer for review. Pre-operatively, normal and system diagnostics revealed high lead impedance. The generator model 102 was explanted, and a replacement model 105 generator was attached to the existing lead and high lead impedance was still found after pin reinsertion/placement. The surgeon reported that he checks the old generator to make sure the pin is past the connector block for any obvious lead breaks when he opens the site, so a generator test on the old model 102 was not necessary per the neurologist's request for the patient to have a new generator. The manufacturer field clinical engineer checked the explanted model 102 out of the field with a test resistor and was within normal limits. Then, the surgeon and scrub visualized a gross lead break after the bifurcation noting there were two kinks and an area where the wire on the old lead was sticking out by one of the electrodes. It was reported that due to the patient's skinny frame, the lead could be seen protruding over the collar bone and the generator could be seen near the collar bone in the chest. This is believed to have been present since vns implant surgery due to the patient's skinny frame. The treating physician wondered if the fracture was near the collar bone where it could be rubbing. Following full system replacement, diagnostics were within normal limits. The patient was closed and second system diagnostic result inside pocket skin closed was normal. The implant card confirmed the reason for full revision on (b)(6) 2013 was due to lead discontinuity. The explanted products were received by the manufacturer for analysis on (b)(4) 2013. However, analysis has not been completed to date.

 
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 a death or serious injury.

 
Manufacturer Narrative

Review of device manufacturing records confirmed that all quality tests were passed for the lead prior to distribution.

 
Event Description

A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. An analysis was performed on the returned lead portions and the reported allegations of lead fracture was confirmed. Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 92mm portion the quadfilar coil 1 appeared to be broken approximately 22mm and 25mm from the electrode bifurcation (in the area of an abraded opening). Scanning electron microscopy was performed on quadfilar coil 1 coil break (found at 22mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type. Scanning electron microscopy was performed on quadfilar coil 1 coil break (found at 25mm) and identified the area on three of the broken quadfilar coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. The area on the fourth broken quadfilar coil strand was identified as being mechanically damaged which prevented identification of the coil fracture type and no pitting. 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. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator. The additional setscrew marks found on the lead connector pin 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, and no other discontinuities were identified.

 
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Brand NameLEAD MODEL 302
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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2978413
Report Number1644487-2013-00512
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/31/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/26/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2008
Device MODEL Number302-30
Device LOT Number1176
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/08/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/08/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/18/2005
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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