FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1834601
·
Received September 9, 2010
Report
- Report Number
- 3007566237-2010-06905
- Event Type
- Malfunction
- Date Received
- September 9, 2010
- Report Date
- August 18, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A MOTOR STALL HAD OCCURRED. PER THE PUMP'S EVENT LOGS, THE MOTOR STALL WAS CONFIRMED, HOWEVER, NO MOTOR STALL RECOVERY WAS RECORDED. THE PT WAS NOTED AS STABLE AND WAS ASYMPTOMATIC. THE HCP INTENDED TO START THE PT ON ORAL MEDICATIONS AS A PRECAUTION TO AVOID UNDER-DOSE AND/OR WITHDRAWAL SYMPTOMS. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. ADDITIONAL INFORMATION IS BEING REQUESTED FROM THE HCP, AND WILL BE PROVIDED IN A FOLLOW-UP REPORT AS IT BECOMES AVAILABLE.
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 | EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8731, LOT# N002780714 |