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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 302-20
Device Problem High impedance
Event Date 06/28/2015
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

It was reported that the vns patient's device showed a high impedance condition during an office visit on (b)(6) 2015. The device subsequently disabled. No known surgical interventions have occurred to date.

 
Event Description

A/p and lateral images of the chest and neck of the vns patient dated (b)(6) 2015 were reviewed. The generator was seen in the chest. The filter feedthru wires were intact. The connector pin inside the connector block was confirmed to be completely inserted. The lead wire was intact at the location of the connector pin; however there was a portion of the lead located behind the generator that could not be assessed. No gross fractures or sharp angles were noted. The radiologist suspected a possible fracture on one of the lead wires at the level of the 2nd posterior rib on the ap view. This was not confirmed on the lateral view per the radiologist. It was noted that the two lead wires intertwine at the 2nd posterior rib but an obvious fracture is not noted. A suspect area was identified in the a/p image taken on (b)(6) 2015. In the lead portion on the clavicle, the lead wires appear to be intertwining again. However, a kink on one of the lead wires is suspected. There did not appear to be any other lead discontinuities in the portion of the lead that could be visualized. However, the presence of a micro-fracture in the lead cannot be ruled out.

 
Event Description

An additional x-ray image was received and reviewed. The 103 generator was seen in the left chest. The filter feedthru wires were intact. The connector pin was inserted into the connector block, but it cannot be determined if it had been inserted to the fullest extent. The lead wire was intact at the location of the connector pin; however, there was a portion of the lead located behind the generator that could not be assessed. The electrode placement was done per labeling. The strain relief bend was present but the strain relief loop was not present. Instead, another bend was in place of the loop. Two tie-downs appear to be present holding the strain relief bend. A possible twist in the lead was noted at the top of the left rib. Between the top left rib and the second left rib, there was a suspect area. It is unknown if this is artifact or if one of the lead wires had been bent. There is an additional suspect area over the left clavicle where the lead appears to have been pinched. It is unclear if a fracture has occurred at this point. The cause of the reported high impedance could not be determined based on the x-ray image received. It was also reported the patient had lead revision surgery on (b)(6) 2016. The lead replacement was due to the high impedance observed and the generator was replaced without any problems. It was noted there were two surgeons present and they had both agreed it was too dangerous to remove the electrodes from the left vagus nerved and decided to implant the new lead on the right vagus nerve. The surgeons had tried for several hours to see if there was a possibility to implant the lead on the left vagus nerve, but were unable to do so. A portion of the lead was removed, but the electrodes remained implanted. After re-implant of the new vns system, impedance values were noted to be fine. No patient adverse events were noted during surgery. The explanted devices are expected to be returned to the manufacturer for analysis; however, they have not been received to date.

 
Event Description

Both the lead and the generator were received by the manufacturer for analysis. Analysis on the generator was completed and a review of the ram/flash data download from the generator shows an indication of increased impedance from 2412 ohms to 13902 ohms on (b)(6) 2015. Various electrical loads were attached to the generator and the results of the diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. A comprehensive automated electrical evaluation showed the generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the generator. Product analysis of the returned lead is expected but has not been completed to date.

 
Event Description

The product analysis for the lead was completed and it was found that the high impedance reported was verified. A break was identified in both the positive and the negative lead coils. Scanning electrode microscopy images of the positive and negative lead coils showed that pitting or electro-etching conditions have occurred at the break locations. Also, the positive lead coil showed minor appearance suggesting that a stress-induced fracture occurred in at least one strand of the positive quadfilar coil. However, due to metal dissolution, mechanical distortion, and/or surface contamination, the fracture mechanism of the broken strands cannot be ascertained. Note that since the electrode array portion was not returned for analysis, an evaluation with resulting commentary could not be made on that portion. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.

 
Manufacturer Narrative

This information was inadvertently reported incorrectly on supplemental #03 mfr. Report.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
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 Key5041455
Report Number1644487-2015-05653
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Type of Report Followup,Followup,Followup,Followup,Followup
Report Date 08/04/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/30/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2017
Device MODEL Number302-20
Device LOT Number202614
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/19/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received06/28/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/14/2013
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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