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 Problem Pain (1994)

Event Date 06/17/2019

Event Type  Injury  

Event Description

It was reported that a patient felt like their generator was going off for prolonged periods of time and is having a burning sensation.Information was received from the patient's treating nurse practitioner that the patient's device was disabled to mitigate the burning sensation, and that surgical intervention is planned for the patient's reported burning.It was stated that the surgical intervention is inspection of the device and lead wire since the patient is uncomfortable.It was stated that the patient's autostimulation is not turned on.Per the physician, he does not believe that the device is staying on for prolonged periods of time, however the patient does have a burning sensation when the device fires.No surgical intervention has been reported to date.No additional relevant information has been received to date.

Manufacturer Narrative

Corrected info; initial mdr inadvertently reported incorrect udi number, and left out lot number when lot number was known at the time of the report.

• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8828038
• MDR Text Key: 152246389
• Report Number: 1644487-2019-01449
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 0542502575006
• UDI-Public: 010542502575006
• 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
• Report Date: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/22/2019
• Device Model Number: 106
• Device Lot Number: 100628
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2017
• 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: 18 YR