FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1052565
·
Received May 22, 2008
Report
- Report Number
- 2182207-2008-02739
- Event Type
- Malfunction
- Date Received
- May 22, 2008
- Date of Event
- April 1, 2008
- Report Date
- April 22, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED A MOTOR STALL OCCURRED. THE DRUG IN THE PUMP WAS MORPHINE 25.0 MG/ML AT A DOSE OF 10.991 MG/DAY AND BUPIVICAINE 1.0 MG/ML AT A DOSE OF 0.4396 MG/DAY. THE MANUFACTURER'S REP NOTED A ROTOR FAILURE. NO SYMPTOMS OR OUTCOME WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
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 | CATHETER MODEL 8709SC| PROGRAMMER MODEL 8840| EXPLANTED| EXPLANTED |