FDA Adverse Event
Death
Summary report: N
PROMETRA PROGRAMMABLE PUMP
MDR report key: 5093697
·
Received September 22, 2015
Report
- Report Number
- 3006803715-2015-00067
- Event Type
- Death
- Date Received
- September 22, 2015
- Date of Event
- August 28, 2015
- Report Date
- August 28, 2015
- Manufacturer
- FLOWONIX MEDICAL, INC
- Product Code
- LKK
- UDI-DI
- 00810335020082
- PMA / PMN Number
- P080012
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
ON (B)(6) 2015, IT WAS REPORTED THAT THE PATIENT EXPIRED DUE TO PRE-EXISTING MEDICAL CONDITIONS. THE DATE OF DEATH AND PRODUCT DISPOSITION ARE UNKNOWN AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT BEGAN TO EXPERIENCE LACK OF PAIN RELIEF. THE PATIENT ALSO EXPRESSED THAT HE WAS FEELING DIZZY AND THERE WAS A CHANGE IN HIS HEARING. AT THE CLINIC, IT WAS OBSERVED THAT THE EXPECTED PUMP RESERVOIR VOLUME DID NOT MATCH THE ASPIRATED VOLUME.
Description of Event or Problem · 1
THE PATIENT EXPIRED ON (B)(6) 2015.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 627005 | PROMETRA PROGRAMMABLE PUMP | IMPLANTABLE INFUSION PUMP | LKK | FLOWONIX MEDICAL, INC | 11827 | 00810335020082 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |