UNKNOWN IMPLANTABLE NEUROSTIMULATOR NEU_INS_STIMULATOR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2019-06-28 for UNKNOWN IMPLANTABLE NEUROSTIMULATOR NEU_INS_STIMULATOR manufactured by Medtronic Neuromodulation.

MAUDE Entry Details

• Report Number: 3007566237-2019-01424
• MDR Report Key: 8744497
• Report Source: HEALTH PROFESSIONAL,LITERATUR
• Date Received: 2019-06-28
• Date of Report: 2019-06-28
• Date of Event: 2019-04-29
• Date Mfgr Received: 2019-05-29
• Date Added to Maude: 2019-06-28
• 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 NEUROMODULATION
• Manufacturer Street: 800 53RD AVE NE
• Manufacturer City: MINNEAPOLIS MN 554211200
• Manufacturer Country: US
• Manufacturer Postal Code: 554211200
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: UNKNOWN IMPLANTABLE NEUROSTIMULATOR
• Generic Name: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Product Code: MRU
• Date Received: 2019-06-28
• Model Number: NEU_INS_STIMULATOR
• Catalog Number: NEU_INS_STIMULATOR
• Lot Number: UNKNOWN
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDTRONIC NEUROMODULATION
• Manufacturer Address: 800 53RD AVE NE MINNEAPOLIS MN 554211200 US 554211200

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-06-28