FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1980016
·
Received January 24, 2011
Report
- Report Number
- 3007566237-2011-00577
- Event Type
- Malfunction
- Date Received
- January 24, 2011
- Date of Event
- January 17, 2011
- Report Date
- January 18, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- 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
THE PATIENT EXPERIENCED A RETURN OF SYMPTOMS. A CONFIRMED MOTOR STALL OCCURRED ON (B)(6) 2011 AND RECOVERED. A SECOND STALL OCCURRED ON (B)(6) 2011 WITH NO MOTOR STALL RECOVERY RECORDED. THE MEDICATION BEING DELIVERED VIA THE DEVICE WAS LIORESAL. 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 | 45 YR | EXPLANTED:| CATHETER: MODEL 8709, LOT # L74357| IMPLANTED: |