FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1980358
·
Received February 3, 2011
Report
- Report Number
- 3007566237-2011-00867
- Event Type
- Injury
- Date Received
- February 3, 2011
- Date of Event
- January 1, 2011
- Report Date
- January 24, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A CONFIRMED PUMP MOTOR STALL WITH A MOTOR STALL RECOVERY WAS REPORTED. THE PATIENT EXPERIENCED WITHDRAWAL. THE PUMP WAS REPLACED. AS FAR AS THE REPORTER KNEW, THE PATIENT DID WELL. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. 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 | 8637 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |