FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED EL
MDR report key: 3202406
·
Received July 2, 2013
Report
- Report Number
- 6000030-2013-00070
- Event Type
- Malfunction
- Date Received
- July 2, 2013
- Report Date
- March 30, 2012
- Manufacturer
- RICE CREEK MFG
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT STATED THE PUMP HAD NOT BEEN WORKING FOR THE LONGEST TIME. THERE WAS A CATHETER PROBLEM BUT THERE WERE ALL JUST DECIDED THEY WERE NOT GOING TO DO ANYTHING WITH IT. THE PUMP HAD SALINE IN IT. THE PHYSICIAN LETTER INDICATED THE CATHETER ¿KINK AND BREAK.¿ DYE STUDY WAS PERFORMED. HYDROMORPHONE, BUPIVACAINE, AND CLONIDINE WERE USED IN THE PUMP SYSTEM. THERE WAS NOT SYMPTOM REPORTED AND THE PATIENT STATUS WAS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 303042 | SYNCHROMED EL | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | RICE CREEK MFG | 8627L18 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00068 YR |