FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 2030875
·
Received March 4, 2011
Report
- Report Number
- 3007566237-2011-01674
- Event Type
- Malfunction
- Date Received
- March 4, 2011
- Date of Event
- February 1, 2011
- Report Date
- February 16, 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
A CONFIRMED PUMP MOTOR STALL WITH NO MOTOR STALL RECOVERY WAS RECORDED IN THE EVENT LOGS. IT WAS NOTED THAT THE PUMP HAD STALLED ONCE BEFORE AND HAD RECOVERED THE NEXT DAY. THE PATIENT EXPERIENCED A RETURN OF SYMPTOMS WITH INCREASED PAIN. THE PUMP WAS USED TO DELIVER SUFENTANIL. 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 | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | IMPLANTED| PROGRAMMER: MODEL 8832, LOT# NJG004808N| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N108716004 |