IFORIA 3 DR-T DF4 383572 SEE MODEL NO.

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 2020-02-19 for IFORIA 3 DR-T DF4 383572 SEE MODEL NO. manufactured by Biotronik Se & Co. Kg.

Event Text Entries

[179963120] After an implantation period of approx. 72 months, it was reported that the device was not interrogative. The patient was hospitalized and the device was explanted.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1028232-2020-00830
• MDR Report Key: 9727338
• Report Source: COMPANY REPRESENTATIVE,FOREIG
• Date Received: 2020-02-19
• Date of Report: 2020-02-03
• Date of Event: 2020-01-28
• Date Mfgr Received: 2020-02-18
• Device Manufacturer Date: 2013-06-03
• Date Added to Maude: 2020-02-19
• 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
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Street: 6024 JEAN ROAD
• Manufacturer City: LAKE OSWEGO OR 97035
• Manufacturer Country: US
• Manufacturer Postal: 97035
• Manufacturer Phone: 8772459800
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: IFORIA 3 DR-T DF4
• Generic Name: ICD
• Product Code: MRM
• Date Received: 2020-02-19
• Returned To Mfg: 2020-02-03
• Model Number: 383572
• Catalog Number: SEE MODEL NO.
• Device Expiration Date: 2014-12-31
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BIOTRONIK SE & CO. KG
• Manufacturer Address: WOERMANNKEHRE 1 BERLIN 12359 DE 12359

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2020-02-19