FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED EL
MDR report key: 1202089
·
Received October 16, 2008
Report
- Report Number
- 6000030-2008-06594
- Event Type
- Malfunction
- Date Received
- October 16, 2008
- Report Date
- September 18, 2008
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
SEE SCANNED PAGE.
Description of Event or Problem · 1
IT WAS REPORTED A RADIOLABELED INDIUM DYE STUDY WAS PERFORMED. THE TEST REVEALED THE DYE WAS NOT GETTING TO THE RIGHT AREAS. NO PATIENT SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE ON THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED EL | LKK | RICE CREEK MANUFACTURING | 8627L18 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | IMPLANTED:| CATHETER: MODEL 8709| EXPLANTED:| PROGRAMMER: MODEL PROGRAMMER |