MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-07-12 for CERVICAL-STIM 2505 manufactured by Orthofix Inc..
[623046]
Pt noted "fluttering" in chest while using magnetic stimulator- cervical-stim model #2505 has implanted av sequential pacemaker for bradycardia. After use, went shopping and passed out. Dates of use: twelve days in 2007. Event abated after use stopped: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5003049 |
| MDR Report Key | 881682 |
| Date Received | 2007-07-12 |
| Date of Report | 2007-07-12 |
| Date of Event | 2007-07-05 |
| Date Added to Maude | 2007-09-17 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CERVICAL-STIM |
| Generic Name | NONE |
| Product Code | OCD |
| Date Received | 2007-07-12 |
| Model Number | 2505 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | Y |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 885277 |
| Manufacturer | ORTHOFIX INC. |
| Manufacturer Address | MCKINNEY TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2007-07-12 |