FDA Adverse Event
Death
Summary report: N
AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE
MDR report key: 17148264
·
Received June 16, 2023
Report
- Report Number
- 2124215-2023-31360
- Event Type
- Death
- Date Received
- June 16, 2023
- Date of Event
- August 28, 2022
- Report Date
- June 16, 2023
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- EZY
- UDI-DI
- 00878953003085
- PMA / PMN Number
- P000053
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) HAS DIED IN THEIR SLEEP AT HOME AND NO AUTOPSY WILL BE PERFORMED. THE DEATH WAS DUE TO NATURAL CAUSES, AND IT IS NOT RELATED TO THE AMS 800 BUT IT WAS CLASSIFIED AS POSSIBLE RELATED TO THE PROCEDURE. THE CAUSE OF DEATH IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 709421 | AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE | DEVICE INCONTINENCE MECHANICAL/HYDRAULIC | EZY | BOSTON SCIENTIFIC CORPORATION | 72404130 | 0072404130 | 00878953003085 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Male | Death | BALLOON: UPN UNK/ LOT 72400024| PUMP: UPN 72404127/ LOT 72404127 |