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

Model Number 381461

Device Problems Loose or Intermittent Connection (1371); Premature End-of-Life Indicator (1480); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 01/12/2016

Event Type  malfunction  

Event Description

Ous mdr - this device was explanted after it reached eos due to more than 200 shocks delivered in a 5.5 hour time span.It is believed this is due to the set screw for the lead becoming loose.

Manufacturer Narrative

Upon receipt, the lead and the implantable cardioverter defibrillator (icd) under complaint were subjected to an extensive analysis.The memory content as well as the therapeutic functionality of the icd were investigated.In the available iegms the occurrence of noise was observed in the ventricular as well as the far-field channel, leading to fast successive charging cycles that predominantly resulted in shock deliveries.The activation of the eos status resulted from that fast successive charging.However, a thorough analysis of the icd proved the device to be fully functional.The performance of the lead was scrutinized, including a visual, mechanical and electrical inspection.The analysis revealed multiple signs of wear along the lead body.In particular in the distal area of the lead the insulation was found rubbed through.This finding can be considered as the root cause of the clinical observations.Based on the characteristics of the damage, it is reasonable to assume that the lead had been subject to severe mechanical stress in the implanted state.Significant motion in the area of the tricuspid valve should be taken into account.Diagnostic images clarifying this assumption were not available.Further damages such as the cuts in the insulation most likely resulted from the explantation procedure.The analysis 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.

• 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: 5516712
• MDR Text Key: 40939692
• Report Number: 1028232-2016-00784
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/29/2016

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?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/29/2016
• Initial Date FDA Received: 03/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2012
• 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