FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 5210210
·
Received November 9, 2015
Report
- Report Number
- 3004209178-2015-22403
- Event Type
- Malfunction
- Date Received
- November 9, 2015
- Report Date
- November 25, 2014
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER. PRODUCT ID: 8590-1, LOT# N213452, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ACCESSORY. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD "WEANED HIMSELF OFF" OF HIS PUMP THERAPY APPROXIMATELY 6-8 MONTHS AGO. THE PATIENT REPORTEDLY HAD CONCERNS ABOUT THE FENTANYL AND HOW STRONG A MEDICATION IT WAS. THE PATIENT'S PUMP WAS ALARMING BECAUSE OF THE EMPTY RESERVOIR. THE PATIENT WAS REFERRED TO THEIR HEALTHCARE PROVIDER (HCP). NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 743126 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00062 YR |