MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ILIVIA 7 HF-T QP DF4 IS4 PROMRI; CRT-D

Model Number 404621

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/19/2019

Event Type  Death  

Event Description

Patient expired on (b)(6) 2019.Device was given to rep by a pima heart pacer technician, asking on behalf of the patients wife for a time of death.Technician advised that device was not turned off, and there were many shocks delivered during the autopsy that overwrote those delivered on (b)(6) 2019.Technician wanted to know if any of the older episodes could be recovered to ensure proper device function.

Manufacturer Narrative

The device was received and analyzed.Upon receipt, the lead fragments were still inserted in the icd header bores.The connections were inspected, showing that the leads were properly connected to the icd.During the visual inspection of the icd, no anomalies were observed.Subsequently the icd was interrogated, showing the battery status bos.The device was implanted for 6 months and 45 charging cycles were documented.The memory content of the icd was inspected.The device therapies were switched on (b)(6) 2019 and still active at the time the patient passed away on (b)(6) 2020.No episodes from (b)(6) 2019 were overwritten and no therapies were delivered on (b)(6) 2019.The data showed a normal device function while the icd was implanted and in service.In a next step, a sensing test was performed and the device sensed the attached heart signals free of noise.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 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 device proved to be fully functional.The analysis of the memory content showed a normal device behavior while the device was implanted and in service.There was no indication of a device malfunction.

• Brand Name: ILIVIA 7 HF-T QP DF4 IS4 PROMRI
• Type of Device: CRT-D
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 10683656
• MDR Text Key: 211471249
• Report Number: 1028232-2020-04444
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 04035479142087
• UDI-Public: 04035479142087
• 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: 01/08/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: 404621
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Initial Date Manufacturer Received: 10/08/2020
• Initial Date FDA Received: 10/15/2020
• Supplement Dates Manufacturer Received: 10/27/2020
• Supplement Dates FDA Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 75 YR