MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LUMAX 640 DR-T; ICD

Model Number 372180

Device Problems Under-Sensing (1661); Battery Problem (2885)

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

Event Date 03/05/2017

Event Type  malfunction  

Event Description

Ous mdr - this icd was explanted and replaced due to lack of detection of a ventricular arrhythmia episode and a warning message of excessive current consumption.

Manufacturer Narrative

Upon receipt, the device interrogation revealed the battery status mol2, 29 charging cycles were documented to the device memory.The memory content of the device was inspected.During the analysis of the available iegms noise was observed in the atrial and ventricular channel as well as in the far field channel, leading to multiple charging cycles, confirming the clinical observation.Therefore a sensing test was performed and showed noise during the sensing of attached heart signals in the atrial and ventricular channel.In a next step the icd was opened and the inner assembly was inspected.The visual inspection of the inner assembly showed no anomalies.Further electrical investigations revealed that an electrostatic discharge protection transistor as a part of the integrated circuit of the electronic module was damaged, causing an elevated current consumption as well as the failure to sense.This type of damage is a typical sign for high voltages which have been applied externally to the device.As it was reported that the patient was defibrillated externally, this is most likely the root cause for the clinical observation.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 which might be related to the clinical observation.Particularly the final acceptance test proved the device functions to be as specified.In conclusion, a damaged integrated circuit on the electronic module was identified that led to an elevated current consumption as well as the failure to sense heart signals free of noise, confirming the clinical observation.The manufacturing records document a normal device production.Based on the available information it is assumed that the damage occurred as a consequence of the reported external defibrillation.For any further questions, please do not hesitate to contact us.

• Brand Name: LUMAX 640 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: 7138321
• MDR Text Key: 95530297
• Report Number: 1028232-2017-04642
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P050023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 372180
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/14/2017
• Initial Date FDA Received: 12/21/2017
• Supplement Dates Manufacturer Received: 03/15/2018
• Supplement Dates FDA Received: 03/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2014
• 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