MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LUMAX 540 HF-T; CRT-D

Model Number 360347

Device Problems Pacemaker Found in Back-Up Mode (1440); Device Displays Incorrect Message (2591)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 07/21/2016

Event Type  malfunction  

Event Description

During a follow-up, this device was displaying eos with an error message regarding the device being in back-up "fail safe" mode.After questioning the patient, it was discovered the patient had surgery recently.Eos was not a true eos.Device was reset with the battery showing 23% and normal device function.

Manufacturer Narrative

We received your event description for the above mentioned device and would like to thank you for supporting our post-market surveillance.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.

Manufacturer Narrative

On (b)(6) 2016 device interrogated in eos.Performed a reset on the device and battery shows 20% again.Since this has happened twice, the doctor decided to get the device changed out soon.Devices remains implanted for now.Updated this to a product problem with malfunction for type of reportable event.

Manufacturer Narrative

(b)(6) 2018 - this device was explanted (b)(6) 2016.We received a device evaluation.Upon receipt the device was interrogated, confirming the battery status eos.The icd was implanted for over 55 months and one charging cycle was recorded to the device memory after the device was reset in the clinic.The memory content of the device was inspected.The inspection revealed one vf episode which resulted from the detection of noise in the rv channel on (b)(6) 2016 at 13:08 o clock.As a result, the charging of a defibrillation shock was started.However, this charging cycle was aborted due to the activation of the battery status eos.Based on the analysis of the memory content it is likely that the application of a magnet in an unfavorable position took place during the episode, prior to eos detection on (b)(6) 2016.An unfavorable orientation in combination with a short distance between the magnet and the device during a charging cycle may lead to such rare clinical events.When there is a short distance between the magnet and the icd, and the orientation of the magnet is aligned to cause the magnetic field to be stronger over the high voltage transformer, a saturation of the transformer may appear during an ongoing charging, leading to a temporary drop of the supply voltage below the eos level, resulting in the observed battery status eos.This anomaly does not represent a device malfunction.This status is only achieved with the combination of an exact position of the magnet over the high voltage transformer, and the reduced distance from device to magnet during a charging cycle.In a next step, the eos status was removed with a technical programmer and subsequent interrogation revealed the battery status mol2.The ability of the device to deliver therapies was verified.The anti-bradycardia pacing pulses proved to be normal and in amplitude and frequency as programmed.A fibrillation signal was applied and the device delivered a defibrillation shock as specified, documenting a correct sensing and shock delivery.In particular, the specified energy level was reached and the charging time was as expected.There was no indication of a device malfunction.

• Brand Name: LUMAX 540 HF-T
• Type of Device: CRT-D
• 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: 5900063
• MDR Text Key: 52865131
• Report Number: 1028232-2016-02900
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/21/2016

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?: No
• Device Operator: Health Professional
• Device Model Number: 360347
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2016
• Initial Date FDA Received: 08/24/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 01/18/2018
• Supplement Dates FDA Received: 09/06/2016; 10/28/2016; 02/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2011
• 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: 87 YR