FDA Adverse Event
Injury
Summary report: N
SYNCHROMED EL
MDR report key: 3142269
·
Received June 3, 2013
Report
- Report Number
- 6000030-2013-00130
- Event Type
- Injury
- Date Received
- June 3, 2013
- Report Date
- May 7, 2013
- Manufacturer
- RICE CREEK MFG
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
CATHETER MODEL: 8703, LOT# J92100929, IMPLANTED: (B)(6) 1992, EXPLANTED: UNK. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP ¿ALMOST KILLED¿ THE PATIENT. IT WAS EXPLANTED IN 2003. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT WHEN IT BECOMES AVAILABLE.
Description of Event or Problem · 1
ADDITIONAL INFORMATION: FOLLOW-UP INFORMATION INDICATED THAT THE CAUSE OF THE EVENT WAS DUE TO AN INFECTED CATHETER. THE PUMP ADMINISTERED BACLOFEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 243359 | SYNCHROMED EL | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | RICE CREEK MFG | 8627L18 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening| R |