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

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 104; 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
 

LIVANOVA USA, INC. PULSE GEN MODEL 104; GENERATOR Back to Search Results
Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Staphylococcus Aureus (2058); Discharge (2225)
Event Date 07/13/2015
Event Type  Injury  
Event Description
During prophylactic generator replacement, the surgeon identified an infection near the generator incision site and opted again implanting a new replacement generator.It was reported that the patient would be reimplanted when the infection is cleared.It was reported that there was oozing drainage that was sent for diagnostics.Further follow-up revealed that the patient had an internal staph infection and will be followed by infectious disease until clearance can be obtained for generator reimplant.Attempts to obtain additional relevant information 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.
 
Event Description
It was reported that the patient was scheduled for re-implant surgery; however, the surgery was cancelled because the patient still had sutures from the explant surgery in (b)(6).The physician was concerned that there was a possibility that the infection was still present.The patient has not been re-implanted to date.
 
Event Description
Information was received that 4 years after the generator explant due to infection, the patient underwent a lead explant due to infection.Due to the 4 year gap between explant procedures, it was not initially assumed that the lead explant was related to the same infection as the generator explant.The lead explant due to infection was previously reported in mfr.Report # 1644487-2019-02385.As it is now known that the explant procedures are related to the same infection, all further investigation and reporting will occur in association with mfr.Report # 1644487-2015-05449, including the assessment of this new information.The physician noted that 2 days prior to the lead explant, the patient presented with dehiscence of the chest wound, and the physician determined that the lead must be explanted for the infection to resolve.The physician reported that the infection that caused the lead explant was a continuation of the same infection that caused the generator explant.Per the physician's assessment, the dehiscence wound is due to the infection.The physician previously indicated that the infection was not related to vns therapy or surgery.A review of device history records showed that the lead was sterilized prior to distribution.No unresolved non-conformances were found.Product return and device evaluation is not necessary as the reported infection and wound dehiscence is not related to the functionality or delivery of therapy of the device.No additional relevant information has been received to date.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PULSE GEN MODEL 104
Type of Device
GENERATOR
Manufacturer (Section D)
LIVANOVA USA, INC.
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
LIVANOVA USA, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
rachel kohn
100 cyberonics blvd
suite 600
houston, TX 77058
2812287200
MDR Report Key4965541
MDR Text Key6196433
Report Number1644487-2015-05449
Device Sequence Number1
Product Code LYJ
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 Health Professional,Company Representative,company representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 01/07/2020
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 Lay User/Patient
Device Expiration Date08/31/2012
Device Model Number104
Device Lot Number2773
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Event Location Other
Initial Date Manufacturer Received 07/13/2015
Initial Date FDA Received08/04/2015
Supplement Dates Manufacturer ReceivedNot provided
12/13/2019
Supplement Dates FDA Received09/15/2015
01/07/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/24/2010
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 Age34 YR
-
-