FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED EL
MDR report key: 744148
·
Received June 23, 2005
Report
- Report Number
- 6000030-2005-00970
- Event Type
- Malfunction
- Date Received
- June 23, 2005
- Date of Event
- May 24, 2005
- Report Date
- June 21, 2005
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
H6-DEVICE ANALYSIS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Description of Event or Problem · 1
THE PT WAS EXPERIENCING INCREASE PAIN. ON 5/24/2005, 2 ROLLER TESTS WERE PERFORMED. THE ROLLER DID NOT TURN ONE TIME AND TURNED ANOTHER. THE PUMP WAS EXPLANTED AND REPLACED DUE TO POSSIBLE GEAR PROBLEMS. THE PT OUTCOME WAS REPORTED AS UNEVENTFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED EL | PUMP | LKK | RICE CREEK MANUFACTURING | 862718 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Hospitalization | CATHETER MODEL 8709AA LOT J11378R14| EXPLANTED:| IMPLANTED: |