ECHOMARK LP
Received Apr 9, 2021 · Event occurred Jan 23, 2020
Report 3014680735-2021-00002 · MDR key 11646254
Device
Generic name
Implantable Radiographic Marker
Manufacturer
Sonavex, Inc.Model number
2000Catalog number
2000
Lot number
P-14526
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
74 YR
- Insufficient Information
- Insufficient Information
Narrative
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.
Description of Event or Problem
PATIENT DEATH REPORTED TO HAVE OCCURRED IN 30 DAY POSTOPERATIVE WINDOW. CAUSE OF DEATH UNKNOWN. NO INDICATION OF IMPLANT INVOLVEMENT.