FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3202666
·
Received July 2, 2013
Report
- Report Number
- 3007566237-2013-01081
- Event Type
- Malfunction
- Date Received
- July 2, 2013
- Date of Event
- June 20, 2012
- Report Date
- June 20, 2012
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2007-(B)(6), PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
A PROBLEM WAS REPORTED. HCP REPORTED A PUMP ALARM DUE TO A LOW RESERVOIR. ALARM DATE WAS REPORTED TO OCCUR ON (B)(6) 2012 AND WAS HEARD BY PATIENT. HOWEVER IT WAS ALSO REPORTED TO OCCUR ON (B)(6) 2012. WITH THESE DATES AND THE FLOW RATE OF THE PUMP, THE HCP WAS ESTIMATING THE PUMP SHOULD HAVE BEEN EMPTY. HCP DID NOT KNOW OF ANY PATIENT¿S SYMPTOMS. PATIENT HAD BEEN RECOVERING FROM ANOTHER SURGERY. A FOLLOW UP HAS BEEN REQUESTED BUT NO ADDITIONAL INFORMATION HAD BEEN PROVIDED AS OF THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A REPORT WILL BE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 301435 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | 863720 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00012 YR |