FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED
MDR report key: 2244061
·
Received August 24, 2011
Report
- Report Number
- 3007566237-2011-06819
- Event Type
- Malfunction
- Date Received
- August 24, 2011
- Date of Event
- July 1, 2011
- Report Date
- July 29, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A PT THOUGHT HIS PUMP WAS "EMPTYING OUT TOO FAST" AND THAT HE WAS GOING INTO MORPHINE WITHDRAWAL. THE RPTR STATED HE THOUGHT THE PT SAID HIS PUMP HAD FLIPPED OVER. THE PUMP CONTAINED MORPHINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED | UNK | LKK | MEDTRONIC NEUROMODULATION | PUMP | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |