FDA Adverse Event
Injury
Summary report: N
SYNCHROMED EL
MDR report key: 1800551
·
Received August 12, 2010
Report
- Report Number
- 6000030-2010-06083
- Event Type
- Injury
- Date Received
- August 12, 2010
- Date of Event
- January 1, 2010
- Report Date
- July 14, 2010
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT WAS ADMITTED TO A HOSPITAL AFTER EXPERIENCING THE FOLLOWING SYMPTOMS: DIZZINESS, CONFUSION, AND FALLING. SYMPTOMS HAD OCCURRED AFTER A PUMP REFILL SESSION CONDUCTED AT THE END OF (B)(6). OVERDOSE WAS SUSPECTED. IT WAS NOTED THAT NO PUMP ALARMS HAD OCCURRED. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED EL | LKK | RICE CREEK MANUFACTURING | 8627-18 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Hospitalization | EXPLANTED:| CATHETER: MODEL 8711, LOT# J10904R48| IMPLANTED: |