MAUDE Adverse Event Report: LIVANOVA USA, INC. ACCESSORY PACK MODEL 502

Model Number	502
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A livanova representative identified that an accessory pack in their trunk stock had a crack in the plastic and this was deemed unsterile.The accessory pack has not been received to date.No other relevant information has been received to date.
Event or Problem Description
Additional information received noting that the accessory pack was found to be cracked upon initial receipt but during a later review of the livanova's representative truck stock.It was also noted that the accessory pack was stored in a backpack and could've been damaged during that time.
Event or Problem Description
Product analysis was completed on the returned accessory pack.Dents and compressed/crushed appearance were on three corners of the outer tray.An opening was noted in the outer tray at one corner.Creases were noted on the outer tray along three sides of the tray.The overall appearance of the outer tray was most likely result of the tray being compressed.No anomalies were noted on the tyvek seal of the outer tray.No anomalies were noted on the inner tray or its tyvek seal.
Event or Problem Description
The suspect product was received but product analysis is still underway.

• Brand Name: ACCESSORY PACK MODEL 502
• Common Device Name: ACCESSORY PACK
• 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: 13538582
• Report Number: 1644487-2022-00158
• Device Sequence Number: 5148280
• Product Code: LYJ
• UDI-Device Identifier: 05425025750245
• UDI-Public: 05425025750245
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/30/2023
• Device Model Number: 502
• Device Lot Number: 4232409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2022
• Supplement Date Received by Manufacturer: 02/21/2022; 03/28/2022; 05/06/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 03/19/2022; 04/22/2022; 05/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown