• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 303

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CYBERONICS, INC. LEAD MODEL 303 Back to Search Results
Model Number 303-20
Event Date 04/01/2012
Event Type  Malfunction  
Event Description

Additional information was received on (b)(6) 2012, that the patient had a full revision. Attempts for product return are underway.

 
Event Description

The explanted lead and generator were returned to the manufacturer on (b)(4) 2012. Analysis has since been completed. During analysis of the lead, a break was identified in the positive coil. Scanning electron microscopy images of the positive coil ends show that pitting or electro-etching conditions have occurred at the break location and in the vicinity of one of the broken ends. Inspection of the positive lead coil indicates a stress-induced fracture has occurred in at least one of the broken strands of the coil. However, due to metal dissolution, mechanical distortion (smoothed surfaces) and/or surface contamination, a conclusive determination of the initial fracture mechanism of the broken strands cannot be determined. The silicone tubing is abraded open near the identified break. Additionally, the lead assembly has remnants of what appears to be dry body fluids inside the silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the ends of the returned lead portions. Analysis on the generator revealed no anomalies. Results of diagnostic testing indicated the device was operating properly. Electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator. Additionally, it was reported by the surgeon, that following the revision, the patient developed vocal cord paralysis. This will be reported under manufacturer's report # 1644487-2012-02752.

 
Event Description

Information was received on 07/27/212 indicating that the surgeon also reviewed the x-rays and did not feel that there as an issue despite identifying the kink in the lead. Additionally he reported that the neurologist would be increasing the patient's output current to determine if that helped. The patient had also previously reported experiencing voice alterations with stimulation as well as that she was unable to perceive magnet mode stimulation. The surgeon had re-instructed that patient on how to perform magnet swipes as he felt that it may have been related to improper swiping technique. Attempts for additional information have been unsuccessful to date.

 
Event Description

Additional information was received on (b)(6) 2012. The patient is continuing to complain of pain in her chest (center) and pain up the side of her left neck. Patient is also not feeling magnet stimulation. Diagnostics were run twice 4065ohms and 4350ohm. The magnet current was increased to 2. 0ma and regular current to 1. 75ma and diagnostics were re-run with impedance 4306ohms and low output current. At these settings the patient began feeling nauseous however this was thought to be related to her headache. It was indicated that the patient had not had a big increase in her seizures. The physician was uncertain if the increase in seizures or depression were associated with vns, however he did indicate that he believed that the pain she was experiencing was related to the irregular impedance values. The myocardial infarction was also not believed to be related to vns. Per the physician, the patient's pain varies so he was uncertain if it was occurring with stimulation, however it was indicated that the device was left programmed on as the patient did not want the device disabled. She has again been referred for revision. It was also noted that there were no causal or contributory programming changes, medication changes, or other external factors precede the onset of the events. Additionally the patient was not experiencing voice alterations, per the physician. Revision is likely but has yet to occur.

 
Manufacturer Narrative

The patient had previously reported voice alterations and failure to perceive magnet stimulation, however this was not included on the initial mdr.

 
Manufacturer Narrative

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

 
Event Description

It was reported on (b)(6) 2012, that a system diagnostic test performed that day at a patient's follow up appointment revealed high impedance, with an impedance value of 8591 ohms. The patient also reported an increase in seizures the past 8 weeks, and also feels uncomfortable in her neck and chest (generator and electrode sites) when she turns her head to the right. It was unclear if the pain was occurring with stimulation. They were not aware of any manipulation or trauma. X-rays were performed and sent to the manufacturer for review. A/p and lateral views of the neck and chest of the vns patient were received and reviewed on (b)(4) 2012. The generator was seen in the left chest. The placement was normal, and the filter feedthrough wires appeared to be intact. The connector pin could be visualized past the second connector block indicating that the pin was fully inserted. A portion of the lead appears to be behind the generator, so continuity in that portion of the lead could not be fully assessed. The lead was routed upwards to the left side of the neck. There appeared to be a suspect area near the generator; however, this could not be fully assessed due to the contrast in the images provided. The lead wire also appeared twisted and kinked in the chest near the neck. No lead discontinuities or sharp angles were seen in the visible portions of the lead; however, it is possible a lead break has occurred in the suspect area near the generator. Additionally a micro-fracture that cannot be seen in the images provided, or a break in the portion of the lead which could not be assessed cannot be ruled out. Clinic notes were also received indicating that the patient had a myocardial infarction that occurred on (b)(6) 2012, and spent two weeks in the hospital for the myocardial infarction and pneumonia. The patient has also had an increase in depression. The relationship between the patient's depression and myocardial infarction and vns therapy is currently unknown. Additionally, the surgeon reported performing diagnostics on (b)(6) 2012, and was questioning the reason for the replacement, as he checked the device on (b)(6) 2012, and the diagnostics showed everything to be ok, with an impedance value in the lower 6000 range. The diagnostics were run 3 times, with the same results. The neurologist also reported performing diagnostics with results in the 5800-6300 ohm range. At this time, the surgeon is hesitant about performing a full revision he indicated that the patient is very large and he is concerned about performing surgery. It is likely that a positional lead break has occurred, which is causing the intermittent impedance issues. No additional information is known at this time.

 
Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLEAD MODEL 303
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 Key2667369
Report Number1644487-2012-01869
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 06/25/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/24/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2015
Device MODEL Number303-20
Device LOT Number2954
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/05/2012
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received10/05/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/28/2011
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/24/2012 Patient Sequence Number: 1
-
-