FDA Adverse Event
Malfunction
Summary report: N
SYCHROMED
MDR report key: 1872244
·
Received October 14, 2010
Report
- Report Number
- 3007566237-2010-07990
- Event Type
- Malfunction
- Date Received
- October 14, 2010
- Date of Event
- September 1, 2010
- Report Date
- September 17, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THERE WAS A CATHETER MALFUNCTION. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS BACLOFEN. 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 | SYCHROMED | LKK | MEDTRONIC NEUROMODULATION | UNK | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | CATHETER: MODEL CATHETER LOT# UNKNOWN| IMPLANTED:| EXPLANTED: |