FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 2043142
·
Received March 25, 2011
Report
- Report Number
- 3007566237-2011-02299
- Event Type
- Malfunction
- Date Received
- March 25, 2011
- Date of Event
- March 1, 2010
- Report Date
- March 10, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PUMP INTERROGATION REVEALED INTERMITTENT PUMP STALLS. NO MOTOR STALL RECOVERY WAS NOTED. THE HCP PLANNED TO REPLACE THE PUMP. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A F/U 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 | 66 YR | IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8731, LOT# N005391535 |