MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ILESTO 7 DR-T DF-1; ICD

Model Number 383562

Device Problems Low impedance (2285); Device Displays Incorrect Message (2591)

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

Event Date 03/12/2014

Event Type  malfunction  

Event Description

Device showed a low rv impedance of less than 200 ohms through home monitoring in february.Today during the lead revision, high battery consumption was indicated by the device.The device was explanted and replaced.

Manufacturer Narrative

Upon receipt, the device was interrogated, revealing the battery status bos.The device was implanted for 20 days and 5 charging cycles were recorded to the device memory.The memory content of the device was inspected.The inspection revealed no indications of a device malfunction.There was no indication towards the root cause for the reported high current consumption.The ability of the device to deliver therapies was verified.The anti-bradycardia pacing pulses proved to be flawless 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.The current consumption of the icd was verified and was within expectation.The impedance measurement functions of the device were tested under in vivo conditions.However, the impedance measurement functions proved to be flawless.In summary, the device was fully functional.There was no indication of device malfunction.Specifically the impedance measurement functions as well as the current consumption were normal and expected.

• Brand Name: ILESTO 7 DR-T DF-1
• 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: 3705383
• MDR Text Key: 4267492
• Report Number: 1028232-2014-00937
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/12/2014

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: 383562
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2015
• Initial Date FDA Received: 03/27/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2013
• 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
• Patient Age: 49 YR