FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN
MDR report key: 2050197
·
Received April 1, 2011
Report
- Report Number
- 3007566237-2011-02519
- Event Type
- Malfunction
- Date Received
- April 1, 2011
- Date of Event
- March 1, 2011
- Report Date
- March 16, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- 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
THE PT'S DEVICE STOPPED WORKING OVER THE WEEKEND. ADD'L INFO HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN | LGW | MEDTRONIC NEUROMODULATION | IPG | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |