FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1930295
·
Received November 24, 2010
Report
- Report Number
- 3007566237-2010-09950
- Event Type
- Malfunction
- Date Received
- November 24, 2010
- Report Date
- November 19, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S CATHETER "GOT TWISTED" AND THE HEALTH CARE PROVIDER WAS ABLE TO UNTWIST WITH HANDS. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | EXPLANTED:| CATHETER: MODEL 8709, LOT# J12566R14| IMPLANTED: |