FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED EL
MDR report key: 1852105
·
Received September 28, 2010
Report
- Report Number
- 6000030-2010-07382
- Event Type
- Malfunction
- Date Received
- September 28, 2010
- Report Date
- September 1, 2010
- Manufacturer
- RICE CREEK MFG
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A PT HAD EXPERIENCED WITHDRAWAL IN THE PAST REGARDING HIS PUMP. IT WAS NOTED THAT NO ALARM HAD BEEN HEARD. IN ADDITION, IT WAS INDICATED THAT "THE DOCTOR STATED THE LAST TIME HE EXTRACTED THE MEDS, THERE WAS TOO MUCH LEFT IN IT." A PUMP REPLACEMENT WAS DISCUSSED. THE PT'S OUTCOME, IN ADDITION TO THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. ADDITIONAL INFO IS BEING REQUESTED FROM THE HCP, AND WILL BE PROVIDED IN A F/U REPORT AS IT BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED EL | LKK | RICE CREEK MFG | 8627L18 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT # N086421019 |