FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3000794
·
Received March 12, 2013
Report
- Report Number
- 3007566237-2013-00761
- Event Type
- Malfunction
- Date Received
- March 12, 2013
- Report Date
- February 12, 2013
- 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 # L67850, IMPLANTED: (B)(6) 1999, PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED REPORTED NO OTHER TROUBLESHOOTING HAD BEEN DONE. THE ACTUAL RESIDUAL VOLUME VERSUS EXPECTED RESIDUAL VOLUME WAS NOT PROVIDED TO THE REPORTER AND IT WAS REPORTED THAT NO CAUSE WAS DETERMINED. IT WAS NOTED THE PROVIDER HAD PASSED ON THE INFORMATION. THE PATIENT WAS REPORTEDLY DOING WELL.
Description of Event or Problem · 1
IT WAS REPORTED THAT THIS PUMP HAS HAD VOLUME DISCREPANCIES AND BELIEVED TO HAVE BEEN WITHIN SPECIFICATION. THIS DEVICE SYSTEM WAS USED TO DELIVER LIORESAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 103710 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | 863740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |