FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 3260289
·
Received August 1, 2013
Report
- Report Number
- 3004209178-2013-12653
- Event Type
- Injury
- Date Received
- August 1, 2013
- Report Date
- July 11, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID: 8709SC LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID: 8709 LOT# SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD BEEN TRANSFERRED TO A HOSPITAL FOR POTENTIAL BACLOFEN WITHDRAWAL. THE PUMP HAD BEEN INTERROGATED AND A PRINT-OUT WAS CREATED, BUT THERE NO KNOWN CAUSE FOR THE EVENT. IT WAS STATED THAT THE PATIENT WAS ¿WITH INJURY¿, THOUGH NO FURTHER DETAILS WERE PROVIDED. THE DEVICE SYSTEM WAS USED TO DELIVER LIORESAL. FOUR DAYS LATER, IT WAS REPORTED THAT A NURSE WAS TRYING TO DISCHARGE THE PATIENT ON THE DATE THAT THE EVENT WAS INITIALLY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 360801 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |