RHYTHMLINK INTL. SUBD *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-06 for RHYTHMLINK INTL. SUBD * manufactured by Rhythmlink International Llc.

Event Text Entries

[6027558] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4914832
• MDR Report Key: 4914832
• Date Received: 2015-07-06
• Date of Report: 2014-02-17
• Date of Event: 2014-01-23
• Report Date: 2014-02-17
• Date Reported to FDA: 2015-07-06
• Date Reported to Mfgr: 2015-07-15
• Date Added to Maude: 2015-07-15
• 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: 3
• 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: RHYTHMLINK INTL. SUBD
• Generic Name: ELECTRODE, NEEDLE
• Product Code: GXZ
• Date Received: 2015-07-06
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: OTHER
• Device Availability: N
• Device Age: 1 DA
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: RHYTHMLINK INTERNATIONAL LLC
• Manufacturer Address: 1140 FIRST STREET SOUTH COLUMBIA SC 29209 US 29209

Patients

Patient Number	Treatment	Outcome	Date
1	0		2015-07-06