FDA Adverse Event
Injury
Summary report: N
SYNCHROMED EL
MDR report key: 3202396
·
Received July 2, 2013
Report
- Report Number
- 6000030-2013-00083
- Event Type
- Injury
- Date Received
- July 2, 2013
- Report Date
- March 20, 2012
- Manufacturer
- RICE CREEK MFG
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID: 8709, LOT# L70454, IMPLANTED: (B)(6) 1999, PRODUCT TYPE: CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP WAS OPERATING INCORRECTLY. THE ¿ROTOR QUIT AND IT JUST SHUT DOWN.¿ THE PATIENT WAS IN PAIN FOR SEVERAL MONTHS BEFORE THE PUMP WAS REMOVED. THE PATIENT OUTCOME WAS UNKNOWN. THE DRUG BEING USED IN THE PUMP WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 301972 | SYNCHROMED EL | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | RICE CREEK MFG | 8627L18 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |