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

MAUDE Adverse Event Report: CYBERONICS - HOUSTON 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 - HOUSTON LEAD MODEL 303 Back to Search Results
Model Number 303-20
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Scarring (2061)
Event Date 07/12/2019
Event Type  Injury  
Manufacturer Narrative
Device evaluation is not necessary as the reported events of bleeding and scarring are not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that during a patient's vns replacement surgery, there was "significant" bleeding caused by heavy scarring of the vagus to internal jugular vein.Due to the bleeding the surgeon considered re-implanting on the right vagus nerve; however, the bleeding was controlled and the physician implanted on the left vagus nerve.The patient historically twisted and manipulated their lead.Device evaluation is not necessary because the reported events of significant bleeding and scarring are not related to the functionality or delivery of therapy of the device.No further relevant information has been received to date.
 
Event Description
Follow up with the surgeon's office revealed that the bleeding was mild to moderate during initial dissection.It was stated that this eventually required intervention by vascular service and was successfully addressed with no residual adverse effects.It was stated that the physician's assessment on the root cause of the heavy scarring was related to the patient's body habitus, to the previous procedure, and to possibly unknown genetic factors.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LEAD MODEL 303
Type of Device
LEAD
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
rachel kohn
100 cyberonics blvd
suite 600
houston, TX 77058
2812287200
MDR Report Key9535572
MDR Text Key173450737
Report Number1644487-2019-02531
Device Sequence Number1
Product Code LYJ
UDI-Device Identifier05425025750115
UDI-Public05425025750115
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date03/12/2023
Device Model Number303-20
Device Lot Number6154
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 12/06/2019
Initial Date FDA Received12/31/2019
Supplement Dates Manufacturer Received01/16/2020
Supplement Dates FDA Received02/10/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/15/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age17 YR
-
-