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 Local Reaction (2035); Post Operative Wound Infection (2446)

Event Date 04/11/2022

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr? device return is not needed as it will not add value to the investigation.

Event Description

It was reported that the patient has an infection.Device history records were reviewed for the lead and generator and both confirmed hp sterilized prior to distribution.No known surgical intervention has occurred to date.No additional relevant information has been received to date.

Event Description

Information was received that the patient did have a good incision site then it turned red/itchy.Patient used neosporin which he did and had a reaction to (skin red & bubbled up) then was draining.He had 10 days of antibiotics.

Manufacturer Narrative

B5.Describe event and f10.Adverse event problem; initial mdr inadvertently omitted information known prior to submission.

• Brand Name: PULSE GEN MODEL 1000
• 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: 14286620
• MDR Text Key: 290767734
• Report Number: 1644487-2022-00519
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/01/2022

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: Health Professional
• Device Expiration Date: 02/26/2023
• Device Model Number: 1000
• Device Lot Number: 573
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/11/2022
• Initial Date FDA Received: 05/05/2022
• Supplement Dates Manufacturer Received: 06/01/2022
• Supplement Dates FDA Received: 06/01/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/26/2022
• 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): Other; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male