FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3203532
·
Received July 3, 2013
Report
- Report Number
- 3007566237-2013-01278
- Event Type
- Malfunction
- Date Received
- July 3, 2013
- Date of Event
- October 8, 2012
- Report Date
- October 11, 2012
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PUMP REACHED END OF LIFE/END OF SERVICE ON (B)(6)-2012, BUT THE PATIENT WAS NOT SCHEDULED FOR A REPLACEMENT SURGERY UNTIL THE NEXT FRIDAY (B)(6)-2012. THE PATIENT WAS IN THE EMERGENCY ROOM DUE TO THE PUMP ALARMING, BUT DID NOT HAVE AN INCREASE IN PAIN. THE PUMP LONGEVITY WAS NORMAL. IT WAS ALSO REPORTED THE PUMP WAS TURNED OFF BY A MANUFACTURER REPRESENTATIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 303944 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | 863720 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00088 YR |