FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 3201528
·
Received July 2, 2013
Report
- Report Number
- 3004209178-2013-04744
- Event Type
- Injury
- Date Received
- July 2, 2013
- Date of Event
- February 10, 2012
- Report Date
- February 14, 2012
- 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
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCT: PRODUCT ID NEU_UNKNOWN_CATH, LOT# UNKNOWN, PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD A CATHETER REVISION. THERE WAS NO CSF RETURN FROM THE CATHETER PRIOR TO THE REVISION. THE ENTIRE CATHETER WAS REPLACED. THE CATHETER WAS NOT AVAILABLE FOR RETURN. THERE WERE NO SYMPTOMS REPORTED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 301560 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00052 YR | Required Intervention |