FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 4221168
·
Received November 3, 2014
Report
- Report Number
- 3004209178-2014-20857
- Event Type
- Injury
- Date Received
- November 3, 2014
- Report Date
- October 9, 2014
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
THE PATIENT HAD A CAR ACCIDENT, AND THEIR CATHETER WAS DAMAGED. THEY EXPERIENCED LESS THAN 50% THERAPY RELIEF. THE PUMP SEGMENT OF THE CATHETER WAS REPLACED ON 2014 (B)(6), AND THE CATHETER ISSUE WAS IDENTIFIED THE DAY OF THIS SURGERY THE PATIENT¿S STATUS AT THE TIME OF THE REPORT WAS ALIVE WITH NO INJURY. THE PUMP CONTAINED MORPHINE. ADDITIONAL INFORMATION WAS REQUESTED TO DETERMINE THE PATIENT¿S OUTCOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 702473 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |