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

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.

• 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 Key: 4965541
• MDR Text Key: 6196433
• Report Number: 1644487-2015-05449
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• 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 Date: 08/31/2012
• Device Model Number: 104
• Device Lot Number: 2773
• 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 Received: 08/04/2015
• Supplement Dates Manufacturer Received: Not provided; 12/13/2019
• Supplement Dates FDA Received: 09/15/2015; 01/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR