INTERSTIM II 3058

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-30 for INTERSTIM II 3058 manufactured by Medtronic Puerto Rico Operations Co..

MAUDE Entry Details

• Report Number: 3004209178-2020-06412
• MDR Report Key: 9901354
• Report Source: CONSUMER
• Date Received: 2020-03-30
• Date of Report: 2020-03-30
• Date of Event: 2019-11-19
• Date Mfgr Received: 2020-03-20
• Device Manufacturer Date: 2019-09-17
• Date Added to Maude: 2020-03-30
• 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 PUERTO RICO OPERATIONS CO.
• Manufacturer Street: ROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK
• Manufacturer City: JUNCOS PR 00777
• Manufacturer Country: US
• Manufacturer Postal Code: 00777
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: INTERSTIM II
• Generic Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Product Code: EZW
• Date Received: 2020-03-30
• Model Number: 3058
• Catalog Number: 3058
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
• Manufacturer Address: ROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK JUNCOS PR 00777 US 00777

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2020-03-30