FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 2061856
·
Received April 4, 2011
Report
- Report Number
- 3007566237-2011-02568
- Event Type
- Malfunction
- Date Received
- April 4, 2011
- Date of Event
- March 17, 2011
- Report Date
- March 23, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- 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
A CONFIRMED MOTOR STALL WAS NOTED IN THE EVENT LOGS ON (B)(6) 2011 AT 0843 WITH NO MOTOR STALL RECOVERY RECORDED. A TUBE SET ERROR MESSAGE OCCURRED. THE PUMP'S ESTIMATED REPLACEMENT INDICATOR WAS 20 MONTHS. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS MORPHINE. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO 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 | 54 YR | EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8598A, LOT# N124097017 |