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

Model Number 360347

Device Problems Premature End-of-Life Indicator (1480); Ambient Noise Problem (2877)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/12/2016

Event Type  Injury  

Event Description

Patients device tripped eos on the same day patient had surgery.Rep informed us that there was a recording on the device showing noise from cautery on the day of the surgery and on the day that the device switched to eos.Went through eos reset and it put the patient back to mol2 with 9% left on the battery.Device remains implanted.

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

Upon receipt, the icd was interrogated, revealing the battery status eri.Four charging cycles were recorded to the icds memory.The amount of charge taken from the battery was verified, indicating the battery status eri to be anticipated.The memory content of the icd was inspected.The inspection showed, that the icd was reset on (b)(6) 2016 as mentioned in the event description and otherwise no anomalies.Due to the reset procedure no device data before the day of reset were available for analysis.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.In a next step, the current consumption of the icd was analyzed and found to be normal and as expected.There was no indication of a device malfunction.Furthermore, the manufacturing process for this device was re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process.Particularly, the final acceptance test proved the device functions to be as specified.There was no indication of a material or manufacturing problem.Based on the analysis and with regard to the event description it is reasonable to assume, that an unfavorable magnet application during the mentioned surgery may have contributed to the clinical event.An unfavorable orientation as well as 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 strongest over the high voltage transformer, a saturation of the transformer may appear during a charging cycle.This will led to a temporary drop of the supply voltage below the eos level, resulting in the battery status eos.This anomaly does not represent a battery or hybrid malfunction.This state only occurs 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 conclusion, analysis showed no indication of a material or manufacturer problem.It is assumed, that an unfavorable magnet application during the mentioned surgery may have contributed to the clinical observation.Biotronik will monitor closely if complaints received in future point towards a common root cause.For this reason we encourage close dialogue between clinicians and our product experts in order to explore all options to minimize any such occurrences in future.

• 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: 5765781
• MDR Text Key: 48670251
• Report Number: 1028232-2016-02195
• 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
• Report Date: 06/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2016
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2009
• 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): Hospitalization
• Patient Age: 84 YR