MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LUMAX 540 HF-T; CRT-D

Model Number 360347

Device Problem Premature Elective Replacement Indicator (1483)

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

Event Date 07/05/2015

Event Type  malfunction  

Event Description

After an implantation period of about 39 months, a battery depletion was reported.The icd was explanted and returned to biotronik for analysis.No adverse patient side effects have been reported.

Manufacturer Narrative

Upon receipt, the device interrogation revealed the battery status eos activated on (b)(6) 2015.The device was implanted for 43 months and a number of 13 charging cycles was documented to the device memory.The icd was subjected to an electrical inspection.The inspection of the battery condition showed a depleted battery, confirming the activated eos state.Therefore, the current consumption of the icd was measured revealing no anomalies.All measured data were found to be normal and as expected.The amount of charge taken from the battery with respect to the battery voltage was verified, revealing an inconsistency.Therefore, the device was opened and the inner assembly inspected.Visually no deficiencies were observed.The eos status was removed with a technical programmer and the electronic module was attached to an external power supply followed by a subsequent analysis.During the thorough analysis no indication for a device malfunction was found, in particular the current consumption of the electronic module was normal and as expected throughout all measurements.Furthermore, the ability of the device to deliver therapies was verified.The anti-bradycardia pacing pulses proved to be normal and in amplitude and frequency as programmed.A fibrillation signal was applied and the device delivered a defibrillation shock as specified, documenting a correct sensing and shock delivery.In particular, the specified energy level was reached and the charging time was as expected.There was no indication of a malfunction of the electronic module.Therefore the battery was sent to the manufacturer for further analysis.The manufacturing records of the battery were inspected, documenting that the battery parameters were within specification during the battery manufacturing.No anomalies were documented during the production process, associated to this battery.The following inspection of the battery did not reveal any signs of damage.The voltage measurement confirmed a depleted battery.There was no indication of a battery failure.In conclusion, despite a thorough analysis of the device no conclusion could be drawn regarding the root cause for the battery status eos.During the analysis the device behavior was found to be normal and as expected.There was no indication for a device malfunction.

• Brand Name: LUMAX 540 HF-T
• Type of Device: CRT-D
• 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: 5330870
• MDR Text Key: 34512438
• Report Number: 1028232-2015-04577
• Device Sequence Number: 1
• Product Code: NIK
• 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: 12/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 360347
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2012
• 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