ACTIVA 37601

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 2019-09-16 for ACTIVA 37601 manufactured by Medtronic Europe Sarl.

MAUDE Entry Details

• Report Number: 9614453-2019-03083
• MDR Report Key: 9071161
• Report Source: COMPANY REPRESENTATIVE,FOREIG
• Date Received: 2019-09-16
• Date of Report: 2019-10-11
• Date of Event: 2017-07-03
• Date Mfgr Received: 2019-09-20
• Device Manufacturer Date: 2017-02-10
• Date Added to Maude: 2019-09-16
• 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: LISA WOODWARD CLARK
• Manufacturer Street: 7000 CENTRAL AVENUE NE RCW215
• Manufacturer City: MINNEAPOLIS MN 55432
• Manufacturer Country: US
• Manufacturer Postal: 55432
• Manufacturer Phone: 7635263920
• 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: ACTIVA
• Generic Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Product Code: MBX
• Date Received: 2019-09-16
• Model Number: 37601
• Catalog Number: 37601
• Device Expiration Date: 2018-07-28
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• 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		2019-09-16