MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2008-01-11 for VECTRA GENISYS 2761 manufactured by Chattanooga Group.
[776905]
Patient described feeling a shock sensation through the muscle stimulator electrodes.
Patient Sequence No: 1, Text Type: D, B5
[7932193]
Previously investigated. Known potential shock and potential burn due to transient over-voltage within the circuitry causing components to fail and potentially shock or burn the patient. En30464 and 30494 implemented preventive software.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022819-2008-00011 |
| MDR Report Key | 979468 |
| Report Source | 08 |
| Date Received | 2008-01-11 |
| Date of Report | 2008-01-09 |
| Date of Event | 2007-08-31 |
| Date Mfgr Received | 2007-08-31 |
| Device Manufacturer Date | 2006-12-01 |
| Date Added to Maude | 2008-04-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MICHAEL TREAS |
| Manufacturer Street | 4717 ADAMS RD. |
| Manufacturer City | HIXSON TN |
| Manufacturer Country | US |
| Manufacturer Phone | 4238702281 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VECTRA GENISYS |
| Generic Name | POWER MUSCLE STIMULATOR |
| Product Code | LIH |
| Date Received | 2008-01-11 |
| Returned To Mfg | 2007-09-12 |
| Model Number | 2761 |
| Catalog Number | 2761 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 981690 |
| Manufacturer | CHATTANOOGA GROUP |
| Manufacturer Address | HIXSON TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-01-11 |