ENRHYTHM MRI SURESCAN EMDR01

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 2019-11-29 for ENRHYTHM MRI SURESCAN EMDR01 manufactured by Medtronic Europe Sarl.

MAUDE Entry Details

• Report Number: 9614453-2019-03998
• MDR Report Key: 9391607
• Report Source: COMPANY REPRESENTATIVE,FOREIG
• Date Received: 2019-11-29
• Date of Report: 2019-11-29
• Date of Event: 2019-11-15
• Date Mfgr Received: 2019-11-18
• Device Manufacturer Date: 2009-12-23
• Date Added to Maude: 2019-11-29
• 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
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: PAULA BIXBY
• Manufacturer Street: 8200 CORAL SEA ST NE
• Manufacturer City: MOUNDS VIEW MN 55112
• Manufacturer Country: US
• Manufacturer Postal: 55112
• Manufacturer Phone: 7635055378
• Manufacturer G1: MEDTRONIC EUROPE SARL
• Manufacturer Street: ROUTE DU MOLLIAU 31 CASE POSTALE
• Manufacturer City: TOLOCHENAZ VAUD 1131
• Manufacturer Country: CH
• Manufacturer Postal Code: 1131
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ENRHYTHM MRI SURESCAN
• Generic Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Product Code: NVZ
• Date Received: 2019-11-29
• Model Number: EMDR01
• Catalog Number: EMDR01
• Device Expiration Date: 2011-06-14
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDTRONIC EUROPE SARL
• Manufacturer Address: ROUTE DU MOLLIAU 31 CASE POSTALE TOLOCHENAZ VAUD 1131 CH 1131

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2019-11-29