CASCADE ELITE 12 N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-03-21 for CASCADE ELITE 12 N/A manufactured by Cadwell Laboratories, Inc..

Event Text Entries

[15206024] Intraoperative monitoring technicians observed differences in the responses (morphology) of the left upper extremity as compared to the right upper extremity. Specifically, the left upper response latency was 2. 5ms earlier with reduced amplitude and the peripheral (erb) had minor peak preceding the assumed actual response. The technicians removed the es-ix stimulator from use replacing it with the es-5-100 stimulator. The program was reset with the same stimulation parameters and monitoring resumed. The responses in question then had higher amplitude, slower response latency, and the peripheral (erb) was without the minor peak. The responses now correlated with the left side. Technician's further explanation: a simplified description is that the patient's "baseline" sensory and/or motor responses are recorded just prior to surgery. All acquired responses from that point on are referenced to the baseline. Changes in the response can occur from many influences, anesthesia, temperature, the position of a limb, or the actual surgical procedure. If there is any change in the response the iom technician needs to determine the cause. If these influences are ruled out and cannot be attributed to causes other than the surgical procedure the technician will notify the surgeon of the change. The surgeon then decides how to proceed.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3752923
• MDR Report Key: 3752923
• Date Received: 2014-03-21
• Date of Report: 2014-03-21
• Date of Event: 2013-12-02
• Report Date: 2014-03-21
• Date Reported to FDA: 2014-03-21
• Date Reported to Mfgr: 2014-04-16
• Date Added to Maude: 2014-04-16
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CASCADE ELITE
• Generic Name: STIMULATOR, PHOTIC, EVOKED RESPONSE
• Product Code: GWE
• Date Received: 2014-03-21
• Model Number: 12
• Catalog Number: N/A
• Lot Number: N/A
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CADWELL LABORATORIES, INC.
• Manufacturer Address: 909 NORTH KELLOGG ST. KENNEWICK WA 99336 US 99336

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-03-21