MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-11-07 for ROMA3 * manufactured by Ivivi Technologies.
[728981]
Trial of roma3 by ivivi in pt with electronic pacemaker. We were told that the pt selected by the co representative would be able to use the device without interference with her pacemaker. When therapy was instituted the second time that day, pt developed shock sensations and multiple electrical pacemaker activity was seen on ekg. Unit was removed and pt has done well. There seems to be no permanent damage. Dates of use: 2007. Diagnosis or reason for use: increased wound healing. Event abated after use stopped or dose reduced: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5004370 |
| MDR Report Key | 946610 |
| Date Received | 2007-11-07 |
| Date of Report | 2007-11-07 |
| Date of Event | 2007-10-30 |
| Date Added to Maude | 2007-11-21 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROMA3 |
| Generic Name | NONE |
| Product Code | ILX |
| Date Received | 2007-11-07 |
| Model Number | ROMA |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 920475 |
| Manufacturer | IVIVI TECHNOLOGIES |
| Manufacturer Address | 224 PEGASUS AVE NORTHVALE NJ 07647 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-11-07 |