MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LUMAX 340 HF-T; CRT-D

Model Number 355263

Device Problems Degraded (1153); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Shock (2072)

Event Date 09/29/2015

Event Type  Injury  

Event Description

Ous mdr - after an implantation time of about 35 months, it was reported that the patient received about 5 shocks.After that, the icd was in backup mode.The icd was explanted but has not yet been returned to biotronik.Aside from the shocks, no further deterioration of the patient's state of health was reported.

Manufacturer Narrative

The returned icd first underwent a status interrogation.The device status was eos, 15 charge processes had been registered.The charge drawn from the battery was checked.The battery depletion proved to be as expected.The device memory of the icd was analyzed.The analysis showed that the icd has detected inconsistent memory content and consequently has automatically activated the safe program (eom/backup mode) on (b)(6) 2015.In general, the device is capable to correct individual memory areas on its own.If several memory areas are affected at the same time, an automatic correction is no longer possible, and the device reacts according to specification with switching to the safe program to ensure patient safety.Matching the clinical observation, the analysis of the device memory also showed several delivered therapies while the safe program was active.As a consequence of that, the icd activated the device status eos on (b)(6) 2015.In general, the safe program is loaded from additional memory that cannot be changed, therefore the vf detection criteria are fixed in the safe program and designed to cover the greatest possible patient population.The inconsistent memory content of the icd was corrected, and the eos mode was reset with the help of a technical programmer.After that, the icd's capability to provide therapy was tested.The antibradycardic output signal was normal and matched the programmed values.A fibrillation signal was supplied, and the device reacted according to specification with a defibrillation shock.The specified energy level was reached, and the charge time proved to be unremarkable.Subsequently, the icd underwent a long-term test at an ambient temperature of 37 deg c.During the entire test period, the icd behaved normally and as expected.Therefore, it cannot be ruled out that the activation of the safe program was triggered by external influences, such as strong electromagnetic radiation or a medical treatment.In summary, the analysis of the device memory data identified inconsistent memory content, which led to the activation of the safe program of the icd.Matching the clinical observation, several therapies were delivered while the safe program was active, which led to the activation of the eos mode on (b)(6) 2015.After correction of the inconsistent memory content and reset of the eos state, the therapeutic functionality of the icd was tested extensively.The icd proved to be fully functional.There were no indications of a device malfunction.

• Brand Name: LUMAX 340 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: 5192709
• MDR Text Key: 29995114
• Report Number: 1028232-2015-03938
• 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: 10/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 355263
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2011
• 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