FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1230564
·
Received November 13, 2008
Report
- Report Number
- 2182207-2008-07460
- Event Type
- Injury
- Date Received
- November 13, 2008
- Date of Event
- October 1, 2008
- Report Date
- October 16, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPERIENCED A MORPHINE OVERDOSE. THE PT WAS UNRESPONSIVE AT THE TIME OF THE REPORT. THE REPORTER REQUESTED A FAXED COPY OF THE MFR'S OVERDOSE PROCEDURE. NO OTHER INFO WAS PROVIDED. ADDITIONAL INFO 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 | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EXPLANTED:| CATHETER: MODEL 8709| PROGRAMMER: MODEL 8840| EXPLANTED:| ACCESSORY: MODEL 8590-1| PROGRAMMER: MODEL 8832 |