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

Model Number 392412

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Ambient Noise Problem (2877)

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

Event Date 01/22/2019

Event Type  Injury  

Event Description

Patient experienced inappropriate shock.Physician was unsure if inappropriate shock was due to rv lead or this device.To prevent risk of future inappropriate shocks, the leads were capped and the device was explanted.A new system was then implanted on the right side.Should additional information be received, this file will be updated.

Manufacturer Narrative

Upon receipt, the icd was interrogated, revealing the battery status mos1.The icd was implanted for 20 months and 14 charging cycles were recorded to the device memory.The memory content of the device was analyzed.During the analysis of the available iegms noise was observed in the right ventricular channel.Therefore a sensing test was performed, and the device sensed the attached heart signals free of noise, proving the sensing function of the icd to be fully functional.There was no indication of a device malfunction.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.In conclusion, the memory content as well as the therapeutic functionality of the icd were inspected.In the available iegms the occurrence of noise was observed in the right ventricular channel.However, a thorough analysis of the icd proved the device to be fully functional.

• Brand Name: ITREVIA 7 DR-T DF-1
• Type of Device: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 8373738
• MDR Text Key: 137255923
• Report Number: 1028232-2019-00796
• Device Sequence Number: 1
• Product Code: MRM
• UDI-Device Identifier: 04035479128807
• UDI-Public: (01)04035479128807
• Combination Product (y/n): N
• PMA/PMN Number: P050023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: 392412
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2019
• Date Manufacturer Received: 06/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 79 YR