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 Dyspnea (1816); Pain (1994); Numbness (2415)

Event Date 04/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Clinic notes were received from a visit dated (b)(6) 2018 providing the patient will have a pocket revision due to pain as an x-ray showed the generator has migrated.The patient explains the pain began in (b)(6).It was also noted the patient feels shortness of breath and numbness into her left shoulder and arm.Impedance on (b)(6) 2018 showed impedance within normal limits.Follow-up from the provider indicated the patient states the vns had moved after being placed.Generator replacement surgery.The explanted device has not been received by the manufacturer to-date.Additional relevant information has not been received to-date.

Event Description

Follow-up from the surgeon provided that the cause of the migration was due to a suture that had broken, and that the migration was causing discomfort.A non-absorbable suture had been used.

Event Description

The explanted generator was returned for analysis.Analysis has not been completed to date.No additional relevant information was received to date.

Event Description

Product analysis was completed for the returned generator.Both interrogation and diagnostics were performed and resulting status checks were within normal limits, showing intensified follow-up indicator=no.The output signal was monitored for more than 24 hours while the generator was placed in a simulated body temperature environment.Magnet activations were tested and an electrical evaluation was also performed.The device performed according to functional specifications with no issues.No additional relevant information was 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: 7747257
• MDR Text Key: 115934655
• Report Number: 1644487-2018-01324
• 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,Followup
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/25/2017
• Device Model Number: 106
• Device Lot Number: 4541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2015
• 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: 29 YR