MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

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

Patient Problems Foreign Body Reaction (1868); Post Operative Wound Infection (2446)

Event Date 07/31/2020

Event Type  Injury  

Event Description

It was reported that the patient had swelling at the incision site after surgery which lead to a visit to the emergency room but no intervention was reported to have occurred.Additional information was later received that the patient complained of having facial numbness, nerve damage and unable to hear from left ear since implant.The patient reported to the surgeon that their incision was infected but he told them it was fine.The patient reported to have ended up having a staph infection.Device history records for the generator was reviewed.The generator passed final quality and functional specifications prior to release.The generator was sterilized prior to being distributed.No additional relevant information has been received to date.

Event Description

Additional information was received from the physician that there was no indication of a staph infection and no intervention was taken as there was no indication of an infection at time of visit.It was indicated that the surgical site looked to be healing appropriately.The report of facial numbness, nerve damage, and hearing loss of left ear were noted as not applicable from the response of the physician.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 1000
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 11382019
• MDR Text Key: 233692963
• Report Number: 1644487-2021-00259
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2022
• Device Model Number: 1000
• Device Lot Number: 205270
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 43 YR