MAUDE Adverse Event Report: LIVANOVA USA, INC. SYMMETRY GEN MODEL 8103; GENERATOR

Model Number 8103

Device Problems High impedance (1291); Incomplete or Inadequate Connection (4037)

Patient Problems Discomfort (2330); Hypoesthesia (2352); No Known Impact Or Consequence To Patient (2692); Shock from Patient Lead(s) (3162); Unspecified Respiratory Problem (4464)

Event Date 01/08/2020

Event Type  malfunction  

Event Description

It was reported that a patient's device was showing high impedance.The patient is also experiencing tingling.No additional relevant information has been received to date.

Event Description

Information was received that the patient's device has had slight increase in impedance values.No additional relevant information has been received to date.

Event Description

It was reported that the patient's impedance has been increasing since implant and is now >10,000 ohms.It was noted that the patient had no trauma and had diagnostics performed with their head in multiple positions.The patient has intermittent jaw pain.Ap and lateral chest and neck x-rays were reviewed.The connector pin does not appear to be fully inserted in the connector block, as the back of the pin is sticking out farther than usual and the pin cannot be seen through the second connector block.The feedthru wires appear intact.The lead was visualized in the chest and neck.No sharp angles were observed in the lead.The lead was assessed for fractures and no gross fractures or discontinuities were noted.The lead wires appear intact at the connector pin.Based on the x-rays received, the cause of the high impedance is likely due to incomplete pin insertion.Note that the presence of problems in obscured portions of the lead and microfractures cannot be ruled out.No further relevant information has been received to date.No known relevant surgical intervention has occurred to date.

Manufacturer Narrative

F10.Code e0752 used.Proposed second level coding - voice alteration to capture hoarseness or other vocal changes.

Event Description

The patient went in for surgery.It was noted that the patient showed symptoms of voice change during pre-op diagnostics.During the surgery, the generator was connected to the test resister and diagnostics revealed normal impedance.The generator was then re-connected to the lead, ensuring that the lead pin was through the connector block with 2 clicks to the set screw, and impedance was normal both out of pocket and in-pocket.Thus no products were replaced.No further relevant information has been received to date.

• Brand Name: SYMMETRY GEN MODEL 8103
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 9655834
• MDR Text Key: 183969836
• Report Number: 1644487-2020-00156
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750115
• UDI-Public: 05425025750115
• 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,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/22/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/12/2021
• Device Model Number: 8103
• Device Lot Number: 205038
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 01/08/2020
• Initial Date FDA Received: 01/31/2020
• Supplement Dates Manufacturer Received: 09/18/2020; 07/29/2021; 09/29/2021
• Supplement Dates FDA Received: 10/13/2020; 08/23/2021; 10/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR