FDA Adverse Event
Injury
Summary report: N
SYNCHROMED EL
MDR report key: 810393
·
Received January 26, 2007
Report
- Report Number
- 6000030-2007-00335
- Event Type
- Injury
- Date Received
- January 26, 2007
- Report Date
- December 27, 2006
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- p860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
HCP REPORTS: PATIENT HAD 1.5T MRI AND PUMP HAD PUMP MEMORY ERROR (PME). THE PATIENT WAS IN THE HCP'S OFFICE EXPERIENCING WITHDRAWAL SYMPTOMS; HOWEVER, NO SPECIFIC SYMPTOMS WERE REPORTED. ACCORDING TO THE MANUFACTURER'S DEVICE REGISTRATION SYSTEM, THE LAST KNOWN DRUG USED IN THE PUMP WAS MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, 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 | LKK | RICE CREEK MANUFACTURING | 862718 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention | CATHETER MODEL 8709AA LOT#J11480R07| EXPLANTED:| PROGRAMMER MODEL PROGRAMMER LOT#UNK| EXPLANTED:| IMPLANTED:| IMPLANTED: |