MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Paralysis (1997)

Event Date 06/18/2018

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr? code 81: device evaluation is not necessary as the infection is not related to the functionality or delivery of therapy of the device.(b)(4).

Event Description

It was reported that this patient received a generator replacement and did not remove his bandage for 7 days post-surgery and the generator site became infected.Additional information was received that the patient had a three day history of pain and redness.The incision site was red, inflamed and swollen, and therefore the surgeon admitted the patient for removal of the battery.It was stated that the patient's device was explanted due to the infection, which was stated to be mrsa.A review of device history records showed that the implanted generator was sterilized prior to distribution.All other quality tests also passed prior to distribution.Product return and device evaluation is not necessary as the reported event is not related to the functionality or delivery of therapy of the device.No other relevant information has been received to date.

Event Description

Additional information was reported that this patient had other surgeries that were related to their vns explant issue.It was clarified that the patient was seen during a follow-up neurology visit where it was stated that the patient apparently had multiple surgeries after his last vns replacement.He has had 4 surgeries including the initial vns replacement.The patient developed an infection over 3 weeks after the initial surgery.At the surgery, a wound wash out was performed to try and save the implant.When the patient was first taken to the or, the surgeon opened up the incision of the generator and washed everything out because it was looking good after his implant.The patient was taken back to surgery on (b)(6) 2018 and explanted the vns generator.Since that time, the surgeon also explanted the lead as the infection was going up the patient's neck and therefore the lead and clips were removed.It was stated that the patient had mrsa.The lead anchor was seen directly under where a pocket of puss was located.Several non-absorbable sutures were in place and these were removed during the explant surgery.There is a wound on the patient's neck indicating the explant of the lead.It was stated that the patient barely has any voice, and it sounds like a whisper, and therefore is being seen by an ent who said that the patient's vocal cords are paralyzed and therefore the patient needs to undergo a scope.The patient has a lot of discomfort from the surgeries, and the patient is very unhappy about the multiple procedures.It was also stated that the patient is an active smoker which could have contributed to the infection risk.Product return and device evaluation is not necessary as the reported event is not related to the functionality or delivery of therapy of the device.No other relevant information has been received to date.

Event Description

Additional information was received from the patient's neurosurgeon who stated that the patient's generator was explanted on (b)(6) 2018 and the lead was explanted several days after that on (b)(6) 2018.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7751663
• MDR Text Key: 116063719
• Report Number: 1644487-2018-01341
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/06/2020
• Device Model Number: 106
• Device Lot Number: 5739
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/27/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/21/2018
• 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: 55 YR