FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2223866
·
Received August 18, 2011
Report
- Report Number
- 3004209178-2011-06538
- Event Type
- Injury
- Date Received
- August 18, 2011
- Date of Event
- January 1, 2011
- Report Date
- July 25, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A CATHETER PROBLEM WAS REPORTED. IT WAS STATED THAT THERE WAS A PROBLEM WITH THE EXISTING CATHETER SO A NEW CATHETER WAS IMPLANTED ON (B)(6) 2011. THE DRUG INFUSED WAS FENTANYL. IT WAS LATER REPORTED THAT THE CATHETER WAS SHEARED BY THE SPINOUS PROCESSES, CONFIRMED BY X-RAY. THERE WAS LACK OF EFFECTIVE THERAPY. FOLLOWING REPLACEMENT, PT WAS RECEIVING EFFECTIVE THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Required Intervention | EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# J11440R23 |