RIATA ACTIVE FIXATION 1580/65

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 2019-11-30 for RIATA ACTIVE FIXATION 1580/65 manufactured by St. Jude Medical, Inc.(crm-sunnyvale).

MAUDE Entry Details

• Report Number: 2938836-2019-16781
• MDR Report Key: 9392639
• Report Source: COMPANY REPRESENTATIVE,FOREIG
• Date Received: 2019-11-30
• Date of Report: 2019-11-30
• Date of Event: 2019-11-18
• Date Mfgr Received: 2019-11-20
• Device Manufacturer Date: 2004-05-19
• Date Added to Maude: 2019-11-30
• 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: ELIZABETH BOLTZ
• Manufacturer Street: 15900 VALLEY VIEW COURT
• Manufacturer City: SYLMAR CA 91342
• Manufacturer Country: US
• Manufacturer Postal: 91342
• Manufacturer G1: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
• Manufacturer Street: 645 ALMANOR AVENUE
• Manufacturer City: SUNNYVALE CA 94085
• Manufacturer Country: US
• Manufacturer Postal Code: 94085
• Single Use: 3
• Remedial Action: RC
• Previous Use Code: 3
• Removal Correction Number: Z-0457-2012
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: RIATA ACTIVE FIXATION
• Generic Name: DEFIBRILLATION LEAD
• Product Code: NVY
• Date Received: 2019-11-30
• Model Number: 1580/65
• Lot Number: 0002164554
• Device Expiration Date: 2007-05-31
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
• Manufacturer Address: 645 ALMANOR AVENUE SUNNYVALE CA 94085 US 94085

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-11-30