FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1843624
·
Received September 22, 2010
Report
- Report Number
- 3004209178-2010-07178
- Event Type
- Injury
- Date Received
- September 22, 2010
- Date of Event
- November 3, 2009
- Report Date
- August 31, 2010
- 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
- AL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A CATHETER KINK/OCCLUSION WAS REPORTED. THE PT WAS NOTED TO HAVE HAD INCREASED PAIN WITHOUT RELIEF FROM PAIN MEDICATION. AN X-RAY AND AN "IT OPIOD" EVALUATION/TEST WAS CONDUCTED ON (B)(6) 2009. THE INTRATHECAL CATHETER WAS EXPLANTED AND REPLACED. THE PT HAD RECOVERED WITHOUT SEQUELAE. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED.
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 | 55 YR | Required Intervention | EXPLANTED:| CATHETER: MODEL 8709, LOT# N094725003| IMPLANTED: |