MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LUMAX 540 DR-T; ICD

Model Number 360346

Device Problem Failure to Transmit Record (1521)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/26/2017

Event Type  malfunction  

Event Description

Device is not transmitting via home monitoring.Device reset completed with normal function and successful link to home monitoring.The patient did not exhibit any adverse events.

Manufacturer Narrative

The device was returned and analyzed.The device memory demonstrated a normal device function while the device was implanted and in service.The bench test of the icd revealed that all therapy functions were available.The charge consumption of the device as well as the battery depletion were normal and as expected.In conclusion the device was fully functional, there was no indication of a device malfunction.Analysis of the device revealed a normal battery depletion.

• Brand Name: LUMAX 540 DR-T
• Type of Device: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin D-123 59; GM D-12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 6304521
• MDR Text Key: 66617033
• Report Number: 1028232-2017-00296
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 360346
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR