FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1628489
·
Received March 4, 2010
Report
- Report Number
- 3007566237-2010-01768
- Event Type
- Malfunction
- Date Received
- March 4, 2010
- Date of Event
- February 5, 2010
- Report Date
- February 5, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B) (4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A PUMP MEMORY ERROR OCCURRED DURING A PUMP UPDATE. IT WAS UNK IF THERE WERE SOURCES OF POTENTIAL EMI PRESENT. THE HCP ATTEMPTED TO UPDATE THE PUMP TWICE, BUT BEFORE THE UPDATE WAS COMPLETED, THE PUMP GAVE A PME WARNING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 8637-20 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 13 YR | IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N238148009| EXPLANTED:| PROGRAMMER: MODEL 8840, LOT# UNK |