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

Model Number 381461

Device Problems Defibrillation/Stimulation Problem (1573); Low impedance (2285)

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

Event Date 11/07/2014

Event Type  malfunction  

Event Description

Ous mdr - it was reported that approximately 29 months after the implant, this device did not shock after the shock induction.External defibrillation was needed.Before this happened there were single events of low shock impedance seen via home monitoring.The low shock impedance could not be reproduced during the provocation tests in hospital.Subsequently the patient underwent a system extraction surgery.

Manufacturer Narrative

Upon receipt, the icd was visually inspected.The visual inspection revealed spots of molten titanium on the icd housing.This indicates an arc over from a high voltage lead conductor during a shock delivery, representing an external short circuit.The icd was subjected to an electrical analysis.Thereby the clinical observation was confirmed, the device was not interrogatable.Next, the icd was opened and the inner assembly was inspected.During the inspection of the electrical module, the analysis revealed that the output stages of the high voltage circuit had been damaged.This damage indicates a shock delivery into an external short circuit.Due to the damage of the electrical module, the device could not be interrogated properly.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.

• Brand Name: LUMAX 740 DR-T PROMRI
• 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: 4403867
• MDR Text Key: 18273057
• Report Number: 1028232-2014-006392
• 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: Invalid Data
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/22/2014

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 381461
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/08/2015
• Initial Date FDA Received: 01/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2012
• 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