FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED EL
MDR report key: 478211
·
Received August 11, 2003
Report
- Report Number
- 6000030-2003-00711
- Event Type
- Malfunction
- Date Received
- August 11, 2003
- Date of Event
- August 3, 2003
- Report Date
- August 8, 2003
- Manufacturer
- RICE CREEK MFG
- Product Code
- LKK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE HCP REPORTED THE PT PRESENTED WITH SUDDEN ONSET OF INCREASED SPASTICITY AND ITCHING. THERE WERE NO RESULTS FROM A PROGRAMMED BOLUS. THE PUMP FAILED THE ROTOR TEST. THERE WAS GOOD CSF FLOW THROUGH THE CAP AND THE PT EXPERIENCED SOME RELIEF WITH A BOLUS THROUGH THE CAP. PT WAS REPORTED TO BE WORSE AGAIN AFTER A DAY. THE PUMP WAS REPLACED AND THE CATHETER WAS SCHEDULED TO BE REPLACED. A FOLLOW UP REPORT WILL BE SENT WHEN ADDITIONAL INFO IS RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED EL | PUMP | LKK | RICE CREEK MFG | 8627L18 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Hospitalization | CATHETER MODEL 8709 LOT# L62216 IMPLANTED: 1999| EXPLANTED: UNK. |