FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED EL
MDR report key: 3200221
·
Received July 1, 2013
Report
- Report Number
- 3007566237-2013-00576
- Event Type
- Malfunction
- Date Received
- July 1, 2013
- Report Date
- May 29, 2009
- Manufacturer
- MEDTRONIC NEUROMODULATION SULLIVAN LAKE
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT¿S PUMP HAD A HISTORY OF STALLING. THE DRUG IN THE PUMP WAS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 299949 | SYNCHROMED EL | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION SULLIVAN LAKE | 8627L18 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |