FDA Adverse Event
Other
Summary report: N
VECTRA GENISYS 2CH
MDR report key: 1002953
·
Received February 5, 2008
Report
- Report Number
- 1022819-2008-00038
- Event Type
- Other
- Date Received
- February 5, 2008
- Date of Event
- January 18, 2008
- Report Date
- February 4, 2008
- Manufacturer
- CHATTANOOGA GROUP
- Product Code
- IPF
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
AWAITING RETURN OF UNIT FOR EVAL.
Description of Event or Problem · 1
PT WAS RECEIVING AN ELECTROTHERAPY TREATMENT IN THE AREA OF THE KNEE. SEVEN MINUTES INTO THE TREATMENT, THE PT BEGAN TO COMPLAINT ABOUT A SHOCKING SENSATION TRAVELING SENSATION TRAVELING UP THEIR LEG. THE PT WAS ASK TO BEGIN A SERIES OF KNEE EXERCISES. DURING THE SEQUENCE OF EXERCISES, THE PT COMPLAINED OF A SHARP BITING FEELING TO THE TREATMENT AREA. THE PT DOES SUFFER WITH HYPERTENSION, NEUROPATHY, CONGESTIVE HEART FAILURE, DIABETIC, AND KNEE PAIN. ADD'L TREATMENT PARAMETERS INCLUDE: TREATMENT SETTINGS = 2-POLE IFC, INTENSITY -15 MINUTES, INTENSITY = 51.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VECTRA GENISYS 2CH | POWER MUSCLE STIMULATOR | IPF | CHATTANOOGA GROUP | 2761 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Other |