FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED EL
MDR report key: 1981396
·
Received February 1, 2011
Report
- Report Number
- 6000030-2011-00778
- Event Type
- Malfunction
- Date Received
- February 1, 2011
- Date of Event
- December 1, 2010
- Report Date
- January 25, 2011
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT EXPERIENCED INCREASED PAIN, BUT DENIED WITHDRAWAL. IT WAS NOTED THAT THE PT HAD A "BAD FLU A MONTH AGO." THE ASPIRATED PUMP VOLUME WAS 15.3 CC; THE EXPECTED VOLUME WAS 3.72. A SIDE PORT DYE STUDY AND ROTOR STUDY WERE DONE; THE CATHETER WAS GOOD, THE ROTOR DID NOT MOVE. THE PT'S ORAL MEDS WERE INCREASED. THE PT WAS BEING SCHEDULED FOR PUMP REPLACEMENT. THE DEVICE SYS WAS USED TO DELIVER SUFENTA AND PRIALT. ADDITIONAL INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.
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 | 56 YR | IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N111036014 |