FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2921022
·
Received January 17, 2013
Report
- Report Number
- 3004209178-2013-00724
- Event Type
- Injury
- Date Received
- January 17, 2013
- Report Date
- December 26, 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
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 8709, LOT# J10924R07, IMPLANTED: 2002-(B)(6), PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S PUMP BEGAN TO LEAK ON (B)(6), WHICH RESULTED IN EMERGENCY REPLACEMENT SURGERY. THE DRUGS USED IN THE SYSTEM WERE DILAUDID, BUPIVACAINE, AND CLONIDINE. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES A VAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 26397 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |