FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED EL
MDR report key: 2244020
·
Received August 24, 2011
Report
- Report Number
- 6000030-2011-06785
- Event Type
- Malfunction
- Date Received
- August 24, 2011
- Date of Event
- January 1, 2011
- Report Date
- August 3, 2011
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ACTUAL RESIDUAL VOLUME WAS LESS THAN THE EXPECTED RESIDUAL VOLUME. SPECIFIC VALUES FOR VOLUMES WERE NOT PROVIDED. HCP (HEALTH CARE PROVIDER) STATED THAT AT THE PREVIOUS TWO REFILLS THEY GOT "5CC EXTRA BACK AND 11CC EXTRA BACK." PATIENT EXPERIENCED RETURN OF SYMPTOMS. THEY WERE CONSIDERING TO REPLACE PUMP AS IT WAS 8 PLUS YEARS OLD AND WOULD ALSO CHECK FOR CATHETER PATENCY AT TIME OF REPLACEMENT. THE DRUGS INFUSED VIA THE PUMP WERE DILAUDID AND CLONIDINE.
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 | 53 YR | IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT# J11486R68 |