MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LUMAX 740 HF-T; CRT-D

Model Number 365608

Device Problem Premature Elective Replacement Indicator (1483)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 12/11/2014

Event Type  malfunction  

Event Description

This device was explanted and replaced due to eri.The rv lead was replaced at the same time due to noise and inappropriate shocks.The hospital retained the device.Should additional information be received, this file will be updated.

Manufacturer Narrative

As of today, the medical device is not available for analysis therefore the device itself could not be investigated.The information you provided has been entered into our quality system as a complaint.These types of complaints are used to evaluate systems and device performance throughout our organization and help to maintain and improve the performance of our devices.Should additional relevant information or the device itself become available, the investigation will be updated.

• Brand Name: LUMAX 740 HF-T
• Type of Device: CRT-D
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin D-12 359; GM D-12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 4371215
• MDR Text Key: 16541421
• Report Number: 1028232-2014-006431
• Device Sequence Number: 1
• Product Code: NIK
• 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: Invalid Data
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 365608
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/08/2015
• Initial Date FDA Received: 12/30/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2013
• 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): Hospitalization
• Patient Age: 84 YR