FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3043566
·
Received April 9, 2013
Report
- Report Number
- 3007566237-2013-01162
- Event Type
- Malfunction
- Date Received
- April 9, 2013
- Report Date
- March 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
CONCOMITANT PRODUCTS: PRODUCT ID 8711, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED, BUT WAS UNABLE TO ASPIRATE THE CATHETER DURING A PUMP REPLACEMENT. THE REASON WAS UNKNOWN. IT WAS QUESTIONED IF WHEN PROGRAMMING THE BACK TABLE PRIME, WHETHER IT COULD GO FASTER THAN 19 MINUTES. IT WAS EXPLAINED THAT 0.3 ML WAS RECOMMENDED AND 19 MINUTES WAS THE SHORTEST DURATION. THE PUMP SYSTEM WAS BEING USED TO DELIVER FENTANYL AND BUPIVACAINE. IT WAS ADDITIONALLY REPORTED THAT THE PUMP WAS REPLACED AND THE PATIENT WAS DOING GREAT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 147005 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | 863740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |