FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1892406
·
Received November 3, 2010
Report
- Report Number
- 3007566237-2010-08792
- Event Type
- Injury
- Date Received
- November 3, 2010
- Date of Event
- January 1, 2010
- Report Date
- October 11, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD AN INFLAMMATORY MASS, WHICH WAS DIAGNOSED VIA MRI. THE HEALTH CARE PROFESSIONAL HAD NOT YET DECIDED UPON MODE OF TREATMENT. 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 | 59 YR | Other | CATHETER: MODEL 8731SC, LOT# N124974001| CATHETER: MODEL 8711, LOT# J10944R09| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 8840, LOT# UNKNOWN| EXPLANTED: |