PROCLAIM 7 ELITE 3662

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-11-30 for PROCLAIM 7 ELITE 3662 manufactured by St. Jude Medical - Neuromodulation.

MAUDE Entry Details

• Report Number: 1627487-2019-13364
• MDR Report Key: 9392294
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2019-11-30
• Date of Report: 2019-11-30
• Date of Event: 2019-10-29
• Date Mfgr Received: 2019-11-12
• Device Manufacturer Date: 2016-10-12
• 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: ANDREA DEITZ
• Manufacturer Street: 6901 PRESTON ROAD
• Manufacturer City: PLANO TX 75024
• Manufacturer Country: US
• Manufacturer Postal: 75024
• Manufacturer Phone: 9723098000
• Manufacturer G1: ST. JUDE MEDICAL - NEUROMODULATION
• Manufacturer Street: 6901 PRESTON RD
• Manufacturer City: PLANO TX 75024
• Manufacturer Country: US
• Manufacturer Postal Code: 75024
• Single Use: 3
• Remedial Action: OT
• Previous Use Code: 3
• Removal Correction Number: 1627487/09/12/2017/001-C
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PROCLAIM 7 ELITE
• Generic Name: SCS IPG
• Product Code: LGW
• Date Received: 2019-11-30
• Model Number: 3662
• Catalog Number: 3662
• Lot Number: 5658638
• Device Expiration Date: 2018-10-12
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ST. JUDE MEDICAL - NEUROMODULATION
• Manufacturer Address: 6901 PRESTON RD PLANO TX 75024 US 75024

Patients

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