FDA Adverse Event
Malfunction
Summary report: N
SYNCRHOMED II
MDR report key: 1812103
·
Received August 17, 2010
Report
- Report Number
- 3007566237-2010-06177
- Event Type
- Malfunction
- Date Received
- August 17, 2010
- Report Date
- July 20, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A CONFIRMED MOTOR STALL OCCURRED, WITH A TUBE SET MESSAGE. THE PATIENT'S CONDITION WAS NOT KNOWN. THE MEDICATION, CONCENTRATION, AND THE DOSE USED IN THE PATIENT'S PUMP WERE NOT REPORTED. NO FURTHER DETAILS, PATIENT SYMPTOMS OR OUTCOME WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCRHOMED II | LKK | MEDTRONIC NEUROMODULATION | 8637 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |