FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2250732
·
Received September 12, 2011
Report
- Report Number
- 3007566237-2011-07752
- Event Type
- Injury
- Date Received
- September 12, 2011
- Date of Event
- September 2, 2011
- Report Date
- September 2, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PUMP HAD AN "ALARM PROPPED UP MOTOR" MESSAGE WHILE THE PT HAD NO MRI. THE MESSAGE CONTINUED TO APPEAR FOLLOWING REPROGRAMMING. THE PUMP WAS REPLACED. THE DRUG BEING ADMINISTERED VIA THE PUMP WAS LIORESAL. ADDITIONAL INFO HAS BEEN REQUESTED.
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 | NA | Male | Required Intervention | UNK. |