FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1063043
·
Received June 19, 2008
Report
- Report Number
- 2182207-2008-03366
- Event Type
- Malfunction
- Date Received
- June 19, 2008
- Report Date
- May 27, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
RESULTS - USED FOR CATHETER.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HEALTH CARE PROVIDER HAD BEEN INCREASING THE DAILY DOSE AND THAT THE PT WAS NOT GETTING ANY RELIEF. A VOLUME DISCREPANCY WAS NOTED AS THE EXPECTED RESERVOIR VOLUME WAS 3.8 ML WHILE THE ACTUAL RESERVOIR VOLUME WAS 6.0 ML. THE PHYSICIAN ACCESSED THE CAP AND WAS UNABLE TO ASPIRATE MEDICATION FROM THE CATHETER. A DYE STUDY WAS NOT PERFORMED FOR THAT REASON. THE CONCENTRATION AND DAILY DOSE OF BACLOFEN BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE ON THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | PROGRAMMER: MODEL 8840 LOT # UNK| IMPLANTED| EXPLANTED| CATHETER: MODEL 8731 |