FDA Adverse Event
Other
Summary report: N
EXTERNAL BONE GROWTH STIMULATOR
MDR report key: 3536481
·
Received December 13, 2013
Report
- Report Number
- 3008524126-2013-00028
- Event Type
- Other
- Date Received
- December 13, 2013
- Date of Event
- October 31, 2013
- Report Date
- December 12, 2013
- Manufacturer
- ORTHOFIX INC.
- Product Code
- LOF
- PMA / PMN Number
- P030034
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
BASED ON THE INFO PROVIDED, PT STATES THAT WHEN EXPERIENCED TWO SEIZURES ON (B)(6) 2013. PRESCRIBING DR IS UNSURE OF WHAT CAUSED THEM. THE PT HAS BEING TREATING WITH DEVICE SINCE (B)(6) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 654640 | EXTERNAL BONE GROWTH STIMULATOR | 2505 CERVICAL STIM | LOF | ORTHOFIX INC. | 652505-0015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Other |