• 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 05/01/2013
Event Type  Injury  
Event Description

The patient had generator and lead replacement surgery on (b)(6) 2013 as captured in manufacturer report number: 1644487-2013-01380. Clinic notes dated (b)(6) 2013 indicated that the patient continued to have coughing episodes and paroxysms of events where she is pointing to her throat. On exam, the patient had increased salivation. Therefore, the vns was taken off of rapid cycling several days ago and programmed at 1. 5 ma. The settings on this visit were then programmed to 1. 0 ma, 30 sec on time, 5 min off time, and 5 hz frequency. Later, clinic notes dated (b)(6) 2013 indicates the mother reported improvement in the patient¿s condition, but the patient continued to experienced cough and intermittently associated emesis. The cough was described as occurring throughout the day, but is most notable at night. She was evaluated by her primary care physician the previous day without provider concerns for intercurrent illness. The mother reported significant difficulties with oral feedings which have were also since device replacement and had timed periods of 5 minutes during which there are no difficulties followed by cough with or without emesis. The neurologist was informed of the issues from the treating nurse and agreed with the surgeon¿s recommendation for a period of rest for the vagus nerve. The vns output current and magnet current were both turned to 0 ma during the visit. The plan was to allow one week of vagal nerve rest. Later, notes dated (b)(6) 2013 report that the patient was admitted with a superficial vns wound infection with wound discharge. She was admitted for wound washout, exploration, and revision. Neurosurgery discharge notes dated (b)(6) 2013 indicate the patient was admitted with diagnosis of surgical wound dehiscence status post-vns replacement, with poor oral intake. The patient was discharged on (b)(6) 2013 with diagnosis of surgical wound dehiscence status post-vns replacement, left vocal cord paralysis, and poor oral intake. The hospital course notes indicate the patient had stimulator replacement on (b)(6) 2013 due to ¿vns malfunction,¿ as captured in manufacturer report number: 1644487-2013-01380. The patient presented to the clinic on (b)(6) 2013 with slight separation of the wound and small amount of white drainage for one day. The mother denied any fevers and seizures. The patient was having a lot of gagging and has not been tolerating any food intake. She lost a few pounds in the prior few days. An ent performed a laryngoscopic exam on the patient on (b)(6) 2013 which demonstrated paralyzed left vocal cord in the paramedian position with mild paryngomalacia. The patient was taken to the operating room on (b)(6) 2013 for a wound washout and revision. Her wound was only superficially dehisced and there was no purulent material seen. An ng tube was placed intraoperatively for nutritional supplemental. During the course of her hospitalization, speech therapy as well as a dietary consult was obtained. Serum electrolytes were monitored to ensure the patient did not develop any electrolyte imbalances from re feeding syndrome. Per speech therapy evaluation, the patient was to be continued on ng feeds. Intraoperative cultures of her wound were negative for bacterial growth. The plan was to complete a 7 day course of keflex. The patient¿s mother was instructed how to perform the ng tube feeds. At time of discharge, the patient was afebrile, voiding, tolerating her ng tube feeds, had good pain control and at her neurological baseline. The plan was for the patient to be admitted for long term monitoring which time speech therapy will be re-evaluating her swallowing function. Attempts for additional information are in progress but have been unsuccessful to date.

Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
MDR Report Key3162932
Report Number1644487-2013-01742
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 05/16/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/11/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2016
Device MODEL Number304-20
Device LOT Number3483
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received05/16/2013
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured12/07/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Date Received: 06/11/2013 Patient Sequence Number: 1