• 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 PULSE GEN MODEL 106; GENERATOR

  • 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 PULSE GEN MODEL 106; GENERATOR Back to Search Results
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Tissue Breakdown (2681)
Event Date 06/05/2018
Event Type  Injury  
Manufacturer Narrative
Code 81 - device evaluation is not necessary because the reported event has been determined as not related to vns therapy but related to the implanting procedure.
 
Event Description
It was reported that a patient was scheduled for a possible full revision due to a lead extrusion.Further updates indicated that the patient had an infection.The patient had stated that after a big seizure, he saw a blue cord showing through his left chest wall.The hole was stated to be the size of a dime at the vns generator incision site.Follow up with the surgeon's office stated that the patient had not been seen since the implant and that he was scheduled for a planned explant, leaving the leads implanted, on 07/23.They had heard the report of extrusion from the patient's girlfriend and assumed that the site was likely infected by now as the patient has had an open wound at his chest incision site.The surgeon's current assumption, based on the call received from the girlfriend, was that the wound opened and the lead was extruding due to a bad seizure that took place.An additional follow up from the surgeon stated that he believed the infection was due to the difficulties that occurred during the implant surgery in which incision sites were reopened for troubleshooting, thereby increasing risk of infection.Explant of the generator was confirmed to have occurred and it was stated that the patient remained in the hospital post-operation for iv antibiotics.The physician confirmed that the extrusion was related to the infection and body's rejection of the device.The infection was confirmed to be in the neck and chest and was determined to be possibly related to surgery.No additional relevant information has been received to date.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PULSE GEN MODEL 106
Type of Device
GENERATOR
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
njemile crawley
100 cyberonics blvd
suite 600
houston, TX 77058
2812287200
MDR Report Key7774054
MDR Text Key116801854
Report Number1644487-2018-01373
Device Sequence Number1
Product Code LYJ
UDI-Device Identifier05425025750061
UDI-Public05425025750061
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
Report Date 08/10/2018
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 Lay User/Patient
Device Expiration Date01/29/2020
Device Model Number106
Device Lot Number204371
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 07/17/2018
Initial Date FDA Received08/10/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/08/2018
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) Required Intervention;
Patient Age26 YR
-
-