MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LUMAX 340 VR-T; ICD

Model Number 355271

Device Problem Difficult to Interrogate (1331)

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

Event Date 06/08/2016

Event Type  malfunction  

Event Description

Ous mdr - on (b)(6) 2016 this icd was implanted with the chronic rv lead as a replacement for the previous device with a depleted battery.The day after the first shock, the device lost telemetry.On (b)(6) 2016 this icd was explanted and replaced.Again, right after the first shock, telemetry was lost on the new device.On (b)(6) both the new icd and the lead were removed from service.The rv lead had to be capped because it got stuck in the superior vena cava.Nothing has been returned for analysis.The patient was a (b)(6) year old male.

Manufacturer Narrative

This icd and the associated icd were returned for investigation and subjected to an extensive analysis.Both icds presented similar damage symptoms.The analysis revealed that the output stages of the high voltage circuit had been damaged in both cases.This damage indicates a shock delivery into an external short circuit, consistent with the spots of molten titanium observed during the visual inspection of the icds and the damaged lead insulation observed during the lead analysis.The analyses of the lead and the icds did not reveal any sign of a material or manufacturing problem.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.

Manufacturer Narrative

On (b)(6) 2017 - received additional analysis report.Upon receipt, the icd was visually inspected.The inspection revealed a spot of molten titanium on the icd housing.This indicates an arc over from a high voltage lead conductor during a shock delivery into an external short circuit, most likely due to the damaged lead insulation.The icd was subjected to an electrical analysis.Thereby the clinical observation was confirmed, the device could not be interrogated.Therefore the icd was opened and the inner assembly inspected.During the analysis of the electronic module, it was revealed that the output stages of the high voltage circuit had been damaged.This damage indicates a shock delivery into an external short circuit, consistent with the spot of molten titanium observed during the visual inspection of the icd and the damaged lead insulation observed during the lead analysis.The damage of the electrical module led to a high current condition, depleting the battery.Therefore the icd could not be interrogated properly.Also the memory content of the device was not restorable as a result of the battery depletion.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 as specified.There was no indication of a material or manufacturing problem.

• Brand Name: LUMAX 340 VR-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: 5806878
• MDR Text Key: 49951111
• Report Number: 1028232-2016-02528
• Device Sequence Number: 1
• Product Code: LWS
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 355271
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2015
• 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