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 Wound Dehiscence (1154); Ecchymosis (1818); Unspecified Infection (1930); Pain (1994)

Event Date 02/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the patient who reported since last implant they have lost 30 lbs over the past 6 months.The device has migrated causing pain at the generator site.The generator is poking out and there is an area in the wound that is opening where the last stitch was located.The issue was noted in february and has gotten worse to the point where the wound in draining with blood.There was no infection reported nor a fever.The generator site was stated to be painful and purple/black.The patient does not think the device is protruding.The patient was informed by neurologist to see pcp before seeing surgeon.During follow-up it was stated that the patient was scheduled for revision surgery as there was a hole in their chest.Additional information was received from the surgeon that the cause of the migration, extrusion and dehiscence wound was patient manipulation.No non-absorbable sutures were used when the generator was implanted.Intervention is planned for the migration, extrusion and dehiscence wound to preclude infectious issues.It was stated that there was no relationship between the weight loss and vns.When asked what the believed cause of the bruising was it was stated none, therefore the cause is likely not known.No settings or diagnostics is known.No surgical intervention has been reported to date.No additional relevant information has been received to date.

Manufacturer Narrative

Device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.

Event Description

Clinic notes for the patient were received indicating the patient returned to the physician for follow-up.It was indicated that the site has become dehiscent and the generator is exposed; pain is minimal and drainage is minimal.The vns incision is swollen and red.The patient is currently on augmentin which is used to treat infection.About 1-1.5 inches of dehiscence incision, incision appears to be intact and uninflammed.The plan it to remove the generator and possible the lead in the or.During follow-up with the surgeon's office, it was confirmed the generator and the majority part of the lead were explanted.It was stated that the cause of the device becoming exposed was a continuation of the patient's infection and the wound not healing and the device was removed to allow the site the heal.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.

Manufacturer Narrative

Event description - correction - inadvertently did not include in supplemental #01 submitted that surgery had occurred and no product was explanted or replaced in patient.

Event Description

Information was received confirming that the patient was taken back to surgery to undergo a revision of the chest incision site.No products were removed or replaced and remained intact.Per the surgeon, the believed cause of the site re-opening was the dual pin [illegible] pushing [illegible] skin and the cause of the infection at the generator site was the lead extrusion.The only site indicated to have an infection and reopening was the chest incision site where the generator is located.

Event Description

Additional information was received from the patient indicating that they have to return to the surgeon as they now have an infection at their generator site and site has re-opened which led her to go to the er.During follow-up with the physician's office, confirmation was received that the patient was taken back to surgery prior to the infection report being received.It was confirmed by the surgeon's office that the wound had slightly re-opened and the re-opening of the wound and infection was a continuation of the previous events.The patient will be taken back to another surgery to place the device deeper so it would not come out and noted that the event was extrusion.The patient's skin was stated to be red with drainage.Per the nurse, the patient was provided with antibiotics and will be given more antibiotics when taken to surgery, therefore there is an infection.Device history records for the generator were reviewed.The generator passed final quality and functional specifications prior to release.Sterilization was confirmed to have been performed on the device prior to distribution.No surgical intervention has been reported to have occurred to date.No additional relevant information has been received to date.

Event Description

Patient reports that her lead that was explanted partially a couple of years ago and the electrodes are now protruding and is red/swollen.The patient is using a topical bactrim antiobiotic that was previously prescribed to her.The patient had explant surgery of the remaining left lead/electrode.Mfr report # 1644487-2022-00309 houses the report with suspect device on the lead.

• 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 8823879
• MDR Text Key: 152112380
• Report Number: 1644487-2019-01421
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750047
• UDI-Public: 05425025750047
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2019
• Device Model Number: 104
• Device Lot Number: 204304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/30/2017
• 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: 61 YR
• Patient Sex: Female