FDA Adverse Event
Injury
Summary report: N
SYNCHROMED EL
MDR report key: 1033612
·
Received April 24, 2008
Report
- Report Number
- 6000030-2008-02176
- Event Type
- Injury
- Date Received
- April 24, 2008
- Date of Event
- January 1, 2008
- Report Date
- March 25, 2008
- Manufacturer
- RICE CREEK MFG
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE PT HAD THE SYSTEM REMOVED A FEW MONTHS AGO DUE TO INFECTION. NO OTHER SYMPTOMS OR OUTCOME WERE REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED FROM HCP, BUT WAS NOT AVAILABLE ON THE DATE OF THE REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED EL | LKK | RICE CREEK MFG | 8627L18 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | PROGRAMMER MODEL PROGRAMMER LOT# UNK| EXPLANTED:| IMPLANTED:| CATHETER MODEL CATHETER LOT# UNK |