FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED EL
MDR report key: 1061527
·
Received June 17, 2008
Report
- Report Number
- 6000030-2008-03289
- Event Type
- Malfunction
- Date Received
- June 17, 2008
- Date of Event
- May 1, 2008
- Report Date
- May 21, 2008
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Removal / Correction Number
- Z-0957-2008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE PUMP MOTOR WAS CONFIRMED TO BE STALLED. A PUMP REPLACEMENT WAS RECOMMENDED. NO PT SYMPTOMS WERE REPORTED. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOES BEING ADMINISTERED VIA THE PUMP WAS NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HCP, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED EL | LKK | RICE CREEK MANUFACTURING | 8627L18 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | EXPLANTED:| CATHETER MODEL 8709| PROGRAMMER MODEL PROGRAMMER |