FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED EL
MDR report key: 1172096
·
Received September 18, 2008
Report
- Report Number
- 6000030-2008-05906
- Event Type
- Malfunction
- Date Received
- September 18, 2008
- Report Date
- August 21, 2008
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A HIGHER VOLUME THAN EXPECTED WAS NOTED AT REFILL. AT TWO PREVIOUS REFILLS, THE FOLLOWING WAS NOTED, EXPECTED RESERVOIR VOLUME 7.1ML AND ACTUAL RESERVOIR VOLUME 10.5ML AND EXPECTED RESERVOIR VOLUME 3.3 ML AND ACTUAL RESERVOIR VOLUME 7.0 ML. THE MOST RECENT VOLUME DISCREPANCY WAS: EXPECTED RESERVOIR VOLUME 5.5 ML AND THE ACTUAL RESERVOIR VOLUME 12.0 ML. THE PT WENT IN FOR A ROTOR STUDY AND THAT WAS "OKAY". THE VOLUME DISCREPANCY HAS "PROGRESSIVELY GOTTEN WORSE." AN EXPLORATORY PROCEDURE WAS BEING PLANNED. THE PT WAS NOT EXPERIENCING ANY SYMPTOMS. THE PUMP CONTAINED MORPHINE 30MG/DL. CLONIDINE 300MCG/ML AND BUPIVICAINE 19MG/ML.
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 | Required Intervention | PROGRAMMER: MODEL PROGRAMMER| CATHETER: MODEL 8709| IMPLANTED:| EXPLANTED |