FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED EL
MDR report key: 1061473
·
Received June 13, 2008
Report
- Report Number
- 6000030-2008-03214
- Event Type
- Malfunction
- Date Received
- June 13, 2008
- Date of Event
- January 31, 2007
- Report Date
- February 12, 2007
- Manufacturer
- RICE CREEK MFG.
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING SENT FOLLOWING AN INTERNAL AUDIT.
Description of Event or Problem · 1
PHYSICIAN REPORTED THE DRUG PUMP WAS INTERROGATED IN 2007, AND REVEALED A PUMP MEMORY ERROR MESSAGE AND STOPPED PUMP FOR 282HRS. ALSO REPORTED WAS THAT THE PT WAS ASYMPTOMATIC. THE PHYSICIAN INDICATED THE PUMP WAS LAST CHANGED WITH THE PROGRAMMER ON 1/31/07 AND A PUMP MEMORY ERROR WAS OBSERVED. MEDTRONIC REP. WAS THERE TO ASSIST WITH REPROGRAMMING, BUT PUMP ALARM CONTINUED TO SOUND. A STOP THERAPY WAS NOT PROGRAMMED AT THAT TIME. PT WAS SENT HOME AND PUMP CONTINUED TO ALARM. DURING THE PROGRAMMING SESSION, A THERAPY STOP WAS PROGRAMMED WHICH CLEARED THE MEMORY ERROR RETURNING THE PUMP TO NORMAL OPERATION. PT WAS BEING TREATED FOR NON-MALIGNANT PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED EL | LKK | RICE CREEK MFG. | 8627L18 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention | CATHETER: MODEL 8709AA| PROGRAMMERS: MODELS 8840 AND 8821 |