FDA Adverse Event
Injury
Summary report: N
SYNCHROMED EL
MDR report key: 1040060
·
Received May 7, 2008
Report
- Report Number
- 6000030-2008-02428
- Event Type
- Injury
- Date Received
- May 7, 2008
- Date of Event
- October 1, 2007
- Report Date
- April 8, 2008
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT'S PUMP WAS REMOVED "BECAUSE HER BODY REJECTED IT". HCP REPORTED THE PT'S SYMPTOMS WERE FEVER AND INFECTION. NO OTHER SYMPTOMS WERE REPORTED. THE DRUG IN THE PUMP WAS MORPHINE. THE CONCENTRATION AND DOSE WAS NOT REPORTED. A CT SCAN WAS PERFORMED IN 2007, WITH INDICATIONS OF SCOLIOSIS, EXTENSIVE POSTERIOR BONY FUSION, AND BILATERAL SI JOINT OSTEOARTHRITIS. THE PT RECOVERED WITH SEQUELA OF CONTINUED BACK AND LOWER EXTREMITY PAIN CAUSING AN INABILITY TO AMBULATE.
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 | CATHETER MODEL 8709| EXPLANTED| PROGRAMMER MODEL PROGRAMMER |