FDA Adverse Event Injury Summary report: N

EEX901 ELECTRICAL STIMULATOR

MDR report key: 1584321 · Received January 18, 2010

Report

Report Number
MW5014436
Event Type
Injury
Date Received
January 18, 2010
Report Date
January 18, 2010
Manufacturer
AXON
Product Code
GWF
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

IN 2010, FEMALE PT UNDERWENT TOTAL POSTERIOR CERVICAL 6-7 DISC REPLACEMENT WITH FUSION. A THOROUGH AND CONTINUING INVESTIGATION IS ONGOING. THE PT HAD BEEN PLACED IN THE PRONE POSITION AND DRAPED AFTER PLACEMENT OF THE ELECTRODES. THE AXON DAQ916 DIGITAL PREAMPLIFIER BOX WAS PLACED NEXT TO THE PT'S NECK. THE NEUROTECHNICIAN COULD NOT VISUALIZE THE BOX AS THE MD WAS STANDING BETWEEN HIM AND THE PT. THE AXON EEX901 ELECTRICAL STIMULATOR, ALL APPEARED TO BE FUNCTIONING WITHOUT ISSUE. DURING THE IRRIGATION OF THE WOUND NEAR THE END OF THE PROCEDURE, SOME OF THE FLUIDS SPLASHED ONTO THE PREAMPLIFIER BOX, WHEN THE DRAPES WERE PULLED AWAY FROM THE PT AND AS THE NEURO-MONITORING TECH WAS REMOVING THE NEEDLE OF THE ELECTRODES CONNECTED TO THE NEURO-TRANSMITTER FROM THE PT'S ARMS, HE NOTED 8 SMALL CIGARETTE SIZE BURNS -0.5MM DIAMETER DARKENED ARAS- AT THE NEEDLE SITES. THERE WERE NO BURNS ON THE SCALP OF EARS WHERE THE OTHER NEEDLE ELECTRODES WERE PLACED. DATES OF USE: 2010. DIAGNOSIS OR REASON FOR USE: C7 CERVICAL RADICULOPATHY SECONDARY TO C6-7 CERVICAL.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 EEX901 ELECTRICAL STIMULATOR NONE GWF AXON EEX901
2 DAQ916 DIGITAL PREAMPLIFIER NONE DRG AXON DAQ916

Patients

Seq Age Sex Outcome Treatment
1 57 YR HP MOBILE PRINTER: MODEL CB064A| IGO AC POWER ADAPTER: MODEL 66300068-0400| MICROSOFT OPTICAL MOSUE: PN X802382| PART# EY688AA#ABA| AXON ECLIPSE NEUROLOGICAL WORKSTATION| 2 CONTAINERS OF VARIOUS ELECTRODES| ADC C - EEX-20 INTERACE CABLE| INTERFACE CABLE| USB PRINTER CABLE| HOSPITAL GRADE AC POWER CORD| HP AC ADAPTER, HP PN: 0957-2257| HP LAPTOP COMPUTER COMPAQ