• 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 Wound Dehiscence (1154); Unspecified Infection (1930); Scarring (2061)
Event Date 03/21/2019
Event Type  Injury  
Manufacturer Narrative
Device evaluation is not necessary because the reported events have been determined as not related to vns therapy.
 
Event Description
It was revealed during the investigation of the patient's recent explant due to infection, which was reported in mfg.Report #1644487-2019-02247, that the patient's previously implanted vns products were explanted due to infection at an unknown time.Follow up with the company representative revealed that the company representative presented to an office visit on approximately three months post-implant to assist the physician.The excerpt from the company representative's notes for the visit stated that the patient experienced slow healing wound post-implant and that there was a possible separation of internal stitches.It was stated that another physician assessed the wound.It was stated that the surgeon had arrived after the representative had already left the appointment and the assessment was unknown.The company representative was confirmed to be present at the vns re-implantation surgery of the most recent products, but was only provided with the patient's initials at this surgery and, therefore, did not know whether the patient was a new patient implant or previous vns patient at the time.It was stated that the patient had been fully draped in the or by the time the company representative had entered the or room and he could not assess whether the patient had a previous implant scar.A review of device history records revealed that the generator and lead were sterilized and passed quality control inspection prior to distribution.No additional relevant information has been received to date.
 
Event Description
Follow up by the company representative revealed that there was no dehiscence wound and that the assessment of a possible separation of internal stitches was speculation on a potential cause of what was suspected/hoped to be a keloid from the surgery.The consulted surgeon hoped that it was a keloid at the site, but prescribed antibiotics prophylactically despite there being no redness, swelling, fever, or other signs of infection.The patient presented for a follow up a week later and it was found to be infected.The patient underwent explant surgery later that day and when the patient's incision was opened, pus was observed.
 
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
rachel kohn
100 cyberonics blvd
suite 600
houston, TX 77058
2812287200
MDR Report Key9350520
MDR Text Key167335657
Report Number1644487-2019-02260
Device Sequence Number1
Product Code LYJ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/17/2019
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 Date09/30/2020
Device Model Number106
Device Lot Number204672
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 06/10/2019
Initial Date FDA Received11/20/2019
Supplement Dates Manufacturer Received11/22/2019
Supplement Dates FDA Received12/17/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/18/2018
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 Age20 YR
-
-