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 Ecchymosis (1818); Erythema (1840); Local Reaction (2035); Post Operative Wound Infection (2446)

Event Date 10/21/2022

Event Type  Injury  

Event Description

It was reported that patient experienced "supposed heating of the generator" and had vns explanted on an unspecified date.There were signs of hematoma in the region of the generator.System diagnostics were reported within normal limits.Device history records were reviewed.The device passed all functional and quality specifications prior to distribution.No other relevant information has been received to date.

Manufacturer Narrative

Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanova's employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects¿ or "malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.

Manufacturer Narrative

H3.Device evaluated by mfr? code 81, device evaluation and return of the device is not necessary.It will not add value to the investigation.

Event Description

It was further reported that patient had an infection and underwent replacement surgery.Device evaluation and return of the device is not necessary.It will not add value to the investigation.No other relevant information has been received to date.

Manufacturer Narrative

H3.Device evaluated by mfr? code 81, device evaluation and return of the device is not necessary.It will not add value to the investigation as the root cause is known.

Event Description

It was later reported that the report of infection was an invalid report as an infection did not occur.The physician has reported that the patient experienced an allergic reaction and that all events were caused by external blow/trauma to the thoracic region.The patient has recovered.Device evaluation is not necessary as the root cause is known and product analysis will add no value to the investigation.No other relevant information has been received to date.

Manufacturer Narrative

D6a.Implant date; corrected data; incorrect implant date was previously reported in error.

Event Description

It was later reported that the physician does believe the device was emitting heat and ultimately was caused by the trauma to the area as previously reported.As the device does not emit heat and this would not be expected from trauma or impact to the device, it is concluded that the heat emitted was due to the allergic reaction at the generator site previously captured in the file.Programming data was received an reviewed.An interrogation on 10/21/2022 showed an ambient temperature of 38.0 c (100.4 f).This value is not outside the operating temperature range of 22-40c.100.4f is also a body and/or local temperature expected when there is an allergic reaction at the generator site as previously reported.The programming data was reviewed in full and no anomalies were seen, no device malfunction occurred.The explanted device has not been received to date.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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 16134359
• MDR Text Key: 307043431
• Report Number: 1644487-2023-00044
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/22/2023

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: 05/22/2021
• Device Model Number: 106
• Device Lot Number: 204941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/21/2022
• Initial Date FDA Received: 01/10/2023
• Supplement Dates Manufacturer Received: 02/17/2023; 04/03/2023; 04/27/2023
• Supplement Dates FDA Received: 03/14/2023; 04/27/2023; 05/22/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/25/2019
• 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