LUMAX 540 DR-T 360346 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 2020-01-30 for LUMAX 540 DR-T 360346 SEE MODEL NO. manufactured by Biotronik Se & Co. Kg.

Event Text Entries

[177067214] On (b)(6) 2020, the battery capacity was found to be 1 percent at a routine follow up. A device replacement was scheduled for (b)(6) 2020. On (b)(6) 2020, an alert through hsmc indicated that the device had reached eos.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1028232-2020-00504
• MDR Report Key: 9650314
• Report Source: COMPANY REPRESENTATIVE,FOREIG
• Date Received: 2020-01-30
• Date of Report: 2020-01-27
• Date of Event: 2020-01-15
• Date Mfgr Received: 2020-01-29
• Device Manufacturer Date: 2012-01-27
• Date Added to Maude: 2020-01-30
• 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
• 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: LUMAX 540 DR-T
• Generic Name: ICD
• Product Code: MRM
• Date Received: 2020-01-30
• Model Number: 360346
• Catalog Number: SEE MODEL NO.
• Device Expiration Date: 2013-04-30
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• 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	2020-01-30