MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG IFORIA 5 VR-T PROMRI DF-1; ICD

Model Number 390119

Device Problems Difficult to Interrogate (1331); Battery Problem (2885)

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

Event Date 10/24/2019

Event Type  malfunction  

Event Description

Icd stimulated at the upper cut-off frequency of the rate response (120 bpm) and was difficult to interrogate, additionally indicating increased power consumption.Replacement was recommended for completely dependent patients.

Manufacturer Narrative

The icd first underwent a status interrogation.The device status was mos1, 29 charge processes had been documented.The device could be interrogated without problems.The memory content of the icd was analyzed and contained expected data.The follow-up data were analyzed.Both on october 23 and october 24 2019, the data showed programming of the basic rate to 60 ppm.The data confirmed an increase in the pacing rate between (b)(6) 18 and 26 2019 in connection with increased patient activity.The analysis of the device memory data from 24 (b)(6) 2019 confirmed a slight increase in power consumption.In a next step, the icds 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 specifications with a defibrillation shock.The specified energy level was reached.The charge time was unremarkable.A long-term study of the current uptake was performed.During the long-term study, the power consumption was normal and as expected.The increased power consumption could not be reproduced.The cause of the clinical observation could therefore not be determined.In addition, the functionality of the motion sensor was examined.To this end, the device was programmed to vvir and 60 ppm.The motion sensor functioned in a regular manner and as expected.The manufacturing process if this device was reviewed.The production documents showed no anomalies.All manufacturing steps had been carried out correctly.A performed standard final electrical test documented proper device behavior; the current uptake of the icd, in particular, was normal.In summary, the device proved to be fully functional during the analysis, and the technical specifications were met.Despite an extensive analysis, the cause of the clinical observation could neither be re-produced nor determined.There was no material defect or manufacturing error.

• Brand Name: IFORIA 5 VR-T PROMRI DF-1
• Type of Device: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 9298214
• MDR Text Key: 165662727
• Report Number: 1028232-2019-04929
• Device Sequence Number: 1
• Product Code: LWS
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: 390119
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Date Manufacturer Received: 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization