NIM-ECLIPSE? PATIENT MODULE OPM660

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-11-09 for NIM-ECLIPSE? PATIENT MODULE OPM660 manufactured by Medtronic Xomed Inc..

MAUDE Entry Details

• Report Number: 1045254-2019-00572
• MDR Report Key: 9301696
• Report Source: COMPANY REPRESENTATIVE,FOREIG
• Date Received: 2019-11-09
• Date of Report: 2019-11-09
• Date Mfgr Received: 2019-10-17
• Device Manufacturer Date: 2014-11-04
• Date Added to Maude: 2019-11-09
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: CHRISTY CAIN
• Manufacturer Street: 6743 SOUTHPOINT DRIVE NORTH
• Manufacturer City: JACKSONVILLE FL 32216
• Manufacturer Country: US
• Manufacturer Postal: 32216
• Manufacturer Phone: 9043328353
• Manufacturer G1: MEDTRONIC XOMED INC.
• Manufacturer Street: 6743 SOUTHPOINT DR N
• Manufacturer City: JACKSONVILLE FL 32216
• Manufacturer Country: US
• Manufacturer Postal Code: 32216
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: NIM-ECLIPSE? PATIENT MODULE
• Generic Name: STIMULATOR, ELECTRICAL, EVOKED RESPONSE
• Product Code: GWF
• Date Received: 2019-11-09
• Returned To Mfg: 2019-10-28
• Model Number: OPM660
• Catalog Number: OPM660
• Lot Number: 208868591
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDTRONIC XOMED INC.
• Manufacturer Address: 6743 SOUTHPOINT DR N JACKSONVILLE FL 32216 US 32216

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-11-09