FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED EL
MDR report key: 1872559
·
Received October 12, 2010
Report
- Report Number
- 6000030-2010-07858
- Event Type
- Malfunction
- Date Received
- October 12, 2010
- Date of Event
- January 1, 2004
- Report Date
- April 22, 2010
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT'S CATHETER "KEPT DISLODGING." AFTER THE FIFTH OCCURRENCE HE ASKED HIS HEALTH CARE PROFESSIONAL TO TURN THE PUMP OFF. THE PUMP WAS TURNED OFF SIX YEARS AGO AND THE PT WANTED TO HAVE THE SYSTEM EXPLANTED. THE MEDICATION BEING DELIVERED VIA THE SYSTEM WAS NOT REPORTED. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED EL | LKK | RICE CREEK MANUFACTURING | 8626-18 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8711, LOT#: L73825| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8711, LOT#: J10973R19| CATHETER: MODEL 8711, LOT#: L74226| IMPLANTED:| EXPLANTED: |