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 Abdominal Pain (1685); Arrhythmia (1721); Dyspnea (1816); Eructate (1839); Fatigue (1849); High Blood Pressure/ Hypertension (1908)

Event Date 12/12/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the patient that she experienced a fluttering in her chest that stops with magnet disablement.The patient stated that this resulted in elevated blood pressure and not sleeping well.The patient later called and described the fluttering as ¿an electrical charge encapsulated in her chest.¿ the patient has been feeling nervous and agitated since the event began.The patient also stated that she felt fatigue and heaviness in her body until she magnet disabled the vns.The patient later reported that she was feeling fatigued and experienced nausea similar in the past when she had an implanted device that contained nickel.The vns lead contains a nickel alloy, but the alloy is encased in silicone and not in contact with the body unless there is an issue.The patient stated that at the last physician's office visit, the diagnostics were "alright".The patient stated that her vns settings were lowered at that time, but the side effects were still lingering.No additional relevant information has been received to date.

Manufacturer Narrative

Describe event or problem, corrected data: follow-up report #2 inadvertently left out information regarding the patient's symptoms causing dyspnea.

Event Description

The patient reported that the symptoms that she had experienced sometimes took her breath away.

Event Description

It was reported by the patient that her symptoms subsided with vns disablement and that her bloodwork came back within normal limits.X-ray images were received and reviewed by the manufacturer.The cause of the patient¿s chest fluttering could not be determined from the images provided.

Manufacturer Narrative

Describe event or problem, corrected data: initial report inadvertently left out that the patient was experiencing belching and gi pain.

Event Description

It was reported that the patient had complaints of gi symptoms (nausea, belching, and pain) as well as fatigue and insomnia.The patient reported that the fluttering sensation improved with less intense stimulation.The patient's vns was later disabled by the physician.The vns diagnostics were within normal limits.It was stated that the patient continued to complain of fatigue, nausea, insomnia, and a fluttering sensation.The patient was to see her pcp regarding the symptoms.X-rays were discussed, but have no x-rays have been reviewed by the manufacturer to date.The patient previously underwent a full vns replacement surgery and it is unknown if a remnant of the previous lead remains implanted in the patient's body.

Event Description

Additional information was received from the patient that the device has been turned off since (b)(6) 2020 and her depression has returned.It was previously known why the patient¿s device was disabled (due to various stimulation related adverse events).The cause of the increase/worsened depression is also known since the depression returned with vns being off; thus indicating the device was efficacious for her depression.The report of the device surging while programmed on is also likely referring to the allegation of fluttering and/or painful stimulation which was also thoroughly investigated prior to the device disablement.No additional information has been received to date.

Event Description

It was reported by the patient that she is planning on having her vns explanted as she continues to experience the previously report adverse events stated to be due to a nickel allergy.Patient was noted to have been seen by a specialist.No known surgery has occurred to date.No additional relevant information has been received.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 9581472
• MDR Text Key: 174894559
• Report Number: 1644487-2020-00075
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/01/2021

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: 11/05/2020
• Device Model Number: 106
• Device Lot Number: 204717
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/19/2019
• Initial Date FDA Received: 01/13/2020
• Supplement Dates Manufacturer Received: 01/31/2020; 02/12/2020; 03/13/2020; 09/11/2020; 05/07/2021
• Supplement Dates FDA Received: 02/05/2020; 03/06/2020; 03/13/2020; 09/21/2020; 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR