• 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

CYBERONICS, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Event Date 12/01/2014
Event Type  Injury  
Event Description

It was reported on (b)(6)2015 that the patient¿s incision is starting to open and the patient¿s mother thinks she can see the lead wires. The patient¿s most recent vns surgery was a full revision on (b)(6) 2014 (captured in file (b)(4)). The mother first noticed it appeared ¿bubbly¿ on (b)(6) 2015 and the physician put the patient on antibiotics. Things then seemed better. However, the morning of (b)(6) 2015 the patient¿s crusty scab fell off and now the patient¿s mother thinks she can see the lead. The patient¿s physician noted that the extrusion was located at the left axilla. He noted that the patient¿s previous re-implants of generators through the initial axillary led to the battery migration laterally to incision twice (b)(6) 2014 and (b)(6) 2015. The physician indicated that the patient has generalized seizures where the patient strikes her chest and has a tendency to pick at the incision line. The first dehiscence was in (b)(6) 2014 and was treated with antibiotics and the generator was placed deeper with layered closure to prevent migration. No causal or contributory medication or diet changes (affecting wound healing) preceded the onset of the extrusion. There was no infection, just exposure to surface bacteria. Cultures showed results of skin flora, ¿staph epi¿.

Event Description

Additional information was received that the patient's lead wires were coming out of the patient's arm pit incision site. The generator is in place but the excess lead has migrated to the arm pit and is extruding from the old incision site. Patient underwent surgery to reposition the lead wires on (b)(6) 2016. Patient manipulation is not suspected to be the cause. According to the surgeon, patient's vns device was originally implanted under the pectoral muscles and generator was in the armpit. In (b)(6) 2015, the leads had extruded out of the skin and the surgeon had gone in and moved the generator to a new location in the chest. He did not move the leads due to risk of damaging it and just routed the leads to the generator in the new location. However now, some of the leads is again extruding out of the skin in the old generator location. He suspects that the contractions of the pectoral muscles are what caused the leads to be pushed and extruded out for both times. The surgeon went back into the area of the extrusion and pushed the leads in further and cleaned out the area. Device was not even taken out of the body and no replacement of products took place. No visible infection was seen. Diagnostics performed afterwards showed everything was ok with 2611 ohms and ifi=no.

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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
MDR Report Key5159327
Report Number1644487-2015-06167
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Type of Report Initial,Followup
Report Date 10/05/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/19/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2018
Device MODEL Number304-20
Device LOT Number3943
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/05/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/14/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Date Received: 10/19/2015 Patient Sequence Number: 1