FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 2062615
·
Received April 5, 2011
Report
- Report Number
- 3007566237-2011-02616
- Event Type
- Malfunction
- Date Received
- April 5, 2011
- Date of Event
- January 1, 2011
- Report Date
- March 24, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A CATHETER DISLODGEMENT AND CATHETER DISCONNECTION FROM THE PUMP WERE CONFIRMED. THE ENTIRE CATHETER WAS "COILED UP BEHIND THE PUMP." IT WAS UNCLEAR WHICH CATHETER HAD THE ISSUES; 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 |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | CATHETER: MODEL 8709SC, LOT # N279764001| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| CATHETER: MODEL 8709SC, LOT # N109370027 |