FDA Adverse Event
Death
Summary report: N
PROMETRA II PROGRAMMABLE PUMP
MDR report key: 6959738
·
Received October 18, 2017
Report
- Report Number
- 3010079947-2017-00148
- Event Type
- Death
- Date Received
- October 18, 2017
- Date of Event
- September 17, 2017
- Report Date
- September 18, 2017
- Manufacturer
- FLOWONIX MEDICAL, INC
- Product Code
- LKK
- UDI-DI
- 00810335020228
- PMA / PMN Number
- P080012
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4). ADDITIONAL INFORMATION WAS RECEIVED ON THE CAUSE OF DEATH.
Description of Event or Problem · 1
PATIENT'S PHYSICIAN REPORTED THAT THE PATIENT PASSED AWAY ON (B)(6) 2017. THE CAUSE OF DEATH IS UNKNOWN. IT IS UNKNOWN IF THE PATIENT'S DEATH IS RELATED TO PUMP THERAPY.
Description of Event or Problem · 1
THE MEDICAL EXAMINER'S OFFICE REPORTED THAT THE PATIENT EXPIRED DUE TO UNDETERMINED NATURAL CAUSES. IT IS NOTED THAT PATIENT HAD MULTIPLE BACK SURGERIES, DIABETES AND OTHER MEDICAL CONDITIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 739731 | PROMETRA II PROGRAMMABLE PUMP | IMPLANTABLE INFUSION PUMP | LKK | FLOWONIX MEDICAL, INC | 13827 | 00810335020228 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |