MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LUMAX 540 DR-T; ICD

Model Number 360346

Device Problem Pacing Problem (1439)

Patient Problems Death (1802); Ventricular Fibrillation (2130)

Event Date 06/12/2015

Event Type  malfunction  

Event Description

Ous mdr - after an implantation period of about 47 months, it was reported that the patient died after unsuccessful resuscitation presumably due to ventricular fibrillation.During rescue, it was observed that the icd reportedly delivered 3 shocks and post shock pacing was at 30 bpm (programmed vvi 65bpm).The patient was also externally shocked 8 times.The icd was returned to biotronik for analysis.

Manufacturer Narrative

Upon receipt, the device was interrogated, revealing the battery status mol1.The device was implanted for 47 months and 13 charging cycles were recorded to the device memory.The inspection of the icd memory revealed no anomalies.The available iegms were inspected, especially the recorded episodes of (b)(6) 2015 were analysed.The first two episodes of (b)(6) 2015, episodes 27 and 28, show a regular detection within the vt1 monitoring zone, according to the programmed zone limits.According to the programming no therapy is delivered in the monitoring zone.All following episodes show a regular detection in the vf zone leading to multiple shock deliveries.The sensing of the icd was set to enhanced t-wave suppression, leading to the observed delay of vf detection.Furthermore, as the icd sensed the present intrinsic signals after shock delivery, no post-shock pacing was delivered.There was no indication of a device malfunction.A dedicated sensing test was performed and the device sensed all applied artificial heart signals free of noise, proving that the sensing functions of the icd were normal and as expected.The icd was subjected to an electrical analysis.The ability of the device to deliver therapies was verified.The anti-bradycardia pacing pulses proved to be flawless 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.In summary, the device proved to be fully functional.The analysis of the available iegms showed a flawless device behaviour while the device was implanted and in service.No therapies were delivered for the first two episodes of (b)(6) 2015 due to the detection in the programmed vt1 monitoring zone.The following episodes show a normal device behavior and a sensing according to the chosen programming, that lead to vf detection and shock delivery.There was no indication of a material or manufacturing problem.

• Brand Name: LUMAX 540 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: 4921636
• MDR Text Key: 20123623
• Report Number: 1028232-2015-02464
• 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
• Report Date: 07/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 360346
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2011
• 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