MAUDE Adverse Event Report: SONAVEX, INC. ECHOMARK LP; IMPLANTABLE RADIOGRAPHIC MARKER

Model Number	2000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/23/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
Communication initially received through study stated the event was unrelated to the device and unrelated to study.New information received from the investigator on 1/28/2021 indicated possible device involvement based on occurrence in 30 day post-operative window and lack of explicit exclusionary evidence.No autopsy was performed.Cause of death is unknown.No evidence of device involvement or malfunction provided.
Event or Problem Description
Patient death reported to have occurred in 30 day postoperative window.Cause of death unknown.No indication of implant involvement.

• Brand Name: ECHOMARK LP
• Common Device Name: IMPLANTABLE RADIOGRAPHIC MARKER
• Manufacturer (Section D): SONAVEX, INC.; 2835 o'donnell st; suite 200; baltimore MD 21224
• MDR Report Key: 11646254
• Report Number: 3014680735-2021-00002
• Device Sequence Number: 3100054
• Product Code: NEU
• UDI-Device Identifier: B53620001
• UDI-Public: B53620001
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K180621
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/26/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/26/2020
• Device Model Number: 2000
• Device Catalogue Number: 2000
• Device Lot Number: P-14526
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 04/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 74 YR
• Patient Weight: 92