FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED EL
MDR report key: 1051462
·
Received May 21, 2008
Report
- Report Number
- 6000030-2008-02679
- Event Type
- Malfunction
- Date Received
- May 21, 2008
- Date of Event
- April 1, 2008
- Report Date
- April 21, 2008
- Manufacturer
- RICE CREEK MFG
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Removal / Correction Number
- Z-0956-2008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE SERIAL NUMBER IS INCLUDED IN THE RANGE FOR THE SYNCHROMED EL PUMP MOTOR STALL, DUE TO GEAR SHAFT WEAR MANUFACTURED BEGINNING SEPTEMBER 1999. PHYSICIAN COMMUNICATION (DATED AUGUST 2007). GEAR SHAFT WEAR HAS NOT BEEN CONFIRMED IN THIS DEVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PT'S INTRATHECAL DRUG DELIVERY PUMP HAD MORE VOLUME THAN EXPECTED AT A REFILL. THE EXPECTED RESERVOIR VOLUME WAS 4 MLS; THE ACTUAL RESERVOIR VOLUME WAS 15 MLS. TROUBLESHOOTING WAS BEING CONSIDERED. NO PT SYMPTOMS WERE REPORTED. ADD'L INFO HAS BEEN REQUESTED 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 MFG | 8627-18 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | PROGRAMMER MODEL PROGRAMMER LOT# UNK| EXPLANTED| CATHETER MODEL 8709 LOT# J11627R58 |