FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED EL
MDR report key: 3203490
·
Received July 2, 2013
Report
- Report Number
- 3007566237-2013-01047
- Event Type
- Malfunction
- Date Received
- July 2, 2013
- Date of Event
- September 10, 2012
- Report Date
- September 28, 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
PRODUCT ID 8709, LOT# L59325, IMPLANTED: 1999-(B)(6), EXPLANTED: 2012-(B)(6), PRODUCT TYPE CATHETER PRODUCT ID 8840, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP WAS ALARMING DUE TO A LOW RESERVOIR VOLUME. THE ALARM OCCURRED BECAUSE THE PUMP WAS NOT UPDATED AT A REFILL 2012-(B)(6). THE PUMP COULD NOT BE INTERROGATED OR UPDATED AT THAT TIME DUE TO AN OUTDATED PROGRAMMER APPLICATION CARD. THE CARD HAD SINCE BEEN REPLACED IN THE PROGRAMMER AND THE PHYSICIAN WAS ABLE TO MANAGE THE PATIENT¿S PUMP. THE PATIENT WAS DOING ¿WELL.¿
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 301451 | SYNCHROMED EL | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | 862718 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00036 YR |