MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LUMAX 740 DR-T; ICD

Model Number 365606

Device Problems Failure to Interrogate (1332); Pacing Problem (1439)

Patient Problem No Code Available (3191)

Event Date 01/12/2015

Event Type  malfunction  

Event Description

An external cardioversion was attempted following and unsuccessful cardioversion through the device.Following the external shock the device was not able to be interrogated.The representative reported that the defibrillation patch was directly over the device.Device explant was recommended.(b)(6) 2015 - we were informed this device was explanted and replaced with a boston scientific device on (b)(6) 2015.

Manufacturer Narrative

Upon receipt, the device could not be interrogated, confirming the clinical observation.Therefore, the device was opened to inspect the inner assembly and to check the functionality of the electronic module.During the analysis of the electronic module, it was revealed that the output stage of one high voltage circuit and several other electric components had been damaged.These damages led to an elevated current consumption, which depleted the battery.Due to this and the damages of the electronic module the device could not be interrogated properly.Based on the damage symptoms of the electronic module, the damages were most probably caused by the reported external defibrillation.In general the icd is protected against the high voltage discharge during external defibrillation, but depending on the position of the external defibrillation electrodes and individual patient circumstances a damage of the electronic module cannot be excluded.In addition 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 observed damage symptoms.Particularly the final acceptance test proved the device functions to be flawless.There was no indication of a material or manufacturing problem.

• Brand Name: LUMAX 740 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: 4445215
• MDR Text Key: 5312116
• Report Number: 1028232-2015-000089
• 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: Invalid Data
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 365606
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2013
• 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: 68 YR