FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1140903
·
Received August 28, 2008
Report
- Report Number
- 2182207-2008-05277
- Event Type
- Malfunction
- Date Received
- August 28, 2008
- Date of Event
- June 1, 2008
- Report Date
- July 28, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED A RETURN OF SYMPTOMS INCLUDING INCREASED BASELINE SPASTICITY. THE EVENT LOGS INDICATED THAT THERE HAD BEEN MULTIPLE MOTOR STALLS AND RECOVERY. THE EVENT LOGS ALSO INDICATED SAFE STATE, LOW BATTERY RESET AND "STOPPED PUMP PERIOD MAY EXCEED TUBE SET". THE PUMP CONTAINED BACLOFEN 2000 MCG/ML AT MINIMUM RATE WITH A DAILY DOSE OF 12.5 MCG/DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF 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 | EXPLANTED:| CATHETER: MODEL 8703W| IMPLANTED:| PROGRAMMER: MODEL 8840 |