FDA Adverse Event
Summary report: N
RHYTHMLINK INTL. SUBD
MDR report key: 4914832
·
Received July 6, 2015
Report
- Report Number
- 4914832
- Date Received
- July 6, 2015
- Date of Event
- January 23, 2014
- Report Date
- February 17, 2014
- Manufacturer
- RHYTHMLINK INTERNATIONAL LLC
- Product Code
- GXZ
- Report Source
- User Facility report
- Reporter Location
- CA, US
Narratives
Description of Event or Problem · 1
PATIENT UNDERWENT A SPINAL FUSION IN OPERATING ROOM 8 WITHOUT COMPLICATIONS. AFTER THE PROCEDURE WAS OVER, BUT BEFORE THE PATIENT LEFT THE OPERATING ROOM WHILE THE NEUROMONITORING NEEDLE ELECTRODES WERE BEING REMOVED FROM THE PATIENT, IT WAS NOTED BY THE NURSE AND NEUROPHYSIOLOGIST THAT THERE WAS A PINPOINT DERMAL DISCOLORATION ON THE RIGHT LATERAL AND ANTERIOR THIGH.PHYSICIAN NOTIFIED.PATIENT #2: AFTER SPINAL FUSION COMPLETED, WHILE REMOVING NEUROMONITORING ELECTRODES, DERMAL DISCOLORATION NOTED ON UPPER RIGHT THIGH. OPERATING ROOM 8.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 434441 | RHYTHMLINK INTL. SUBD | ELECTRODE, NEEDLE | GXZ | RHYTHMLINK INTERNATIONAL LLC | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR | COVIDIEN E7507 LOT 33310138X, CAUTERY PENCILETTE| ELECTROCAUTERY UNITS VALLEY LAB F*H7107A AND| F1H8705A PATIENT RETURN ELECTRODES VALLEY LAB| FROM SPINE PACK LFCMPJ165381 LOT 13GB5927,| ELECTRODE INFORMATION NOT AVAILABLE |