MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Post Operative Wound Infection (2446); No Code Available (3191)

Event Date 08/02/2017

Event Type  Injury  

Event Description

It was reported by a physician on (b)(6) 2017 that a patient¿s device was ¿poking out¿ and the patient presented to the er the week before.He reviewed the patient's device via ultrasound and discovered that the generator had been flipping and had migrated.The surgeon stated that he always sutures the generator in place but that he would have to perform a revision to re-suture the generator in place.The patient then stated she had a lot of chest pain and was going for revision of her pocket because her surgeon told her that it was moving too much.Surgery to secure the generator occurred.The patient later provided on (b)(6) 2017 that the generator was flipping over from 4 months prior, and was moving to her arm.The patient reported this caused tremendous pain, but it was flipped surgically, and re-stitched.Additional relevant information has not been received to-date.

Event Description

The patient then later provided that before the repositioning surgery it felt like she was being strangled over 2-3 minutes apart and she was in excruciating pain.The patient repeated that she was in pain from the generator migration and that when trying to use her arm the generator would turn over 180 degrees.

Event Description

Follow-up from the patient was received providing that he says she had her device adjusted about a year ago and stated the physician had to turn it down because it was too high, and increased her seizure medications.

Event Description

It was later confirmed by the patient that the generator pocket was made slightly deeper during the replacement surgery and that they "shortened the strap" which appeared to be a reference to the vns being re-sutured in place.

Event Description

Additional information was received from the patient noting that the migration of the generator noted to have caused an infection device history records were reviewed for the device.The device passed all functional specifications and quality tests and was hp sterilized prior to distribution.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 103
• 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: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 6960601
• MDR Text Key: 89672538
• Report Number: 1644487-2017-04644
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750030
• UDI-Public: 05425025750030
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/06/2018
• Device Model Number: 103
• Device Lot Number: 5080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2016
• 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: 33 YR
• Patient Sex: Female