FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 2850045
·
Received November 29, 2012
Report
- Report Number
- 3004209178-2012-10898
- Event Type
- Malfunction
- Date Received
- November 29, 2012
- Report Date
- October 31, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, UNK PRODUCT TYPE: CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PUMP WAS BEING REPLACED PROPHYLACTICALLY FOR UPCOMING ELECTIVE REPLACEMENT INDICATOR. THE SURGEON COULD NOT ASPIRATE THE CATHETER. A CATHETER REVISION WAS DONE; THE CATHETER WAS REMOVED. THE HOLES AT THE TIP OF THE CATHETER WERE OCCLUDED WITH A BLACK SUBSTANCE. PATIENT STATUS WAS NOTED AS "ALIVE - NO INJURY/NO ADVERSE EVENT". THERE WERE NO PATIENT SYMPTOMS/INJURIES RELATED TO THIS EVENT. THE PUMP WAS DELIVERING FENTANYL, INFUMORPH, CLONIDINE AND BUPIVICAINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 863740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00064 YR |