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


  • 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

LIVANOVA USA, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-30
Device Problems Tube; Break; Lead
Event Date 10/19/2015
Event Type  Injury  
Manufacturer Narrative

Event Description

It was reported that the patient was experiencing intermittent pain at the generator site. The physician instructed the patient to use the magnet to disable the device to see if the pain was related to device stimulation. The patient was later seen in the emergency room due to the pain and the mother claimed she could feel the device stimulation when touching the patient's chest. The nurse indicated that this may be muscle spasms. It was reported that the physician programmed the device off and then the patient suffered a seizure. The patient was referred to surgery for consult and then scheduled for surgery as the surgeon feels the device needs to be evaluated. The patient underwent exploratory surgery where a break in the lead tubing was identified. The surgeon indicated that there was fluid visible in the tubing. Device diagnostics were within normal limits. The neck incision was opened; however, the surgeon indicated that the vagus nerve was heavily scarred. The lead was cut and explanted along with the generator. The surgeon felt that the nerve was too scarred to implant another vns system and the patient's mother opted not to proceed with reimplant. The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date.

Event Description

Analysis of the generator was completed on 01/04/2016. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the lead was completed on 01/12/2016. Note that a portion of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis the lead assembly appeared to have dried remnants of what appear to have once been body fluids inside the outer silicone tubing, in some areas. An abraded opening was observed on the outer silicone tubing approximately 98mm-100mm from the end of the connector boot. The inner silicone tubes and quadfilar coils appeared to be looped and pulled thru the opening. The abraded opening found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. With the exception of the abraded opening found on the outer silicone tubing, the condition of the returned lead portion is consistent with that which typically exists following an explant procedure. No other obvious anomalies were noted. The 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 portion were performed, during the visual analysis, with no discontinuities identified.

Event Description

The neurologist indicated that the cause of the pain is unknown, but that has resolved since explant. The patient is pursuing medication therapy. The physician is unsure what caused the patient's pain since diagnostics were fine, but that the pain resolved when the device was explanted.

Manufacturer Narrative

This information was inadvertently left off of the initial mfr. Report.

Event Description

Additional information was received from the physician stating he believes vns stimulation was causing the patient's pain. It was also noted that prior to the event, the patient had a seizure, fell, and then began complaining of pain with stimulation. The physician stated the device might have been affected by the fall.

Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLEAD MODEL 304
Type of DeviceLEAD
Manufacturer (Section D)
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
rachel kohn
100 cyberonics blvd
suite 600
houston , TX 77058
MDR Report Key5307942
Report Number1644487-2015-06790
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 05/07/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/17/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2011
Device MODEL Number304-30
Device LOT Number200991
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/03/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received04/29/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/29/2008
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial