FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED EL
MDR report key: 2043188
·
Received March 25, 2011
Report
- Report Number
- 6000030-2011-02311
- Event Type
- Malfunction
- Date Received
- March 25, 2011
- Report Date
- March 10, 2011
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A VOLUME DISCREPANCY WAS REPORTED. THE ACTUAL RESIDUAL VOLUME WAS 5.6ML AND THE EXPECTED RESIDUAL VOLUME WAS 1.4ML. THERE WAS AN AUDIBLE ALARM THAT WAS DUE TO A LOW BATTERY, AND WITHDRAWAL SYMPTOMS OF INCREASED BASELINE SPASTICITY AND PAIN. THE PT WAS BEING TRANSITIONED TO MANAGEMENT OUTSIDE OF THE PUMP AS THE PUMP BATTERY WAS NEARING EOL (END OF LIFE). THE MEDICATION BEING DELIVERED VIA THE DEVICE WAS LIORESAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
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 | IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT# J11143R46 |