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

Model Number	383597
Medical Device Problem Code	Premature Elective Replacement Indicator (1483)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
After an implantation period of approx.74 months, it was reported that the device shows the eri status.The icd was explanted.This device is affected by the field safety notice bio-lqc, published on march 3, 2021.
Additional Manufacturer Narrative
Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this icd were re-investigated.All production steps were performed accordingly, and in particular the final acceptance test proved the device functions to be as specified.Next, the icd was subjected to an electrical analysis, revealing that the device could not be interrogated.In order to obtain further insights, the icd was opened and the inner assembly was inspected.The visual inspection showed no anomalies.The overall current consumption of the electronic module was verified by direct measurement and proved to be normal and as expected.There was no indication of a malfunction of the electronic module.Battery voltage measurement confirmed a depleted battery, which could be attributed to increased internal self-depletion within the battery.Please note that this icd is affected by the field safety corrective action, bio-lqc, initiated in march 2021.

• Brand Name: IFORIA 5 VR-T DX DF-1
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 12158849
• Report Number: 1028232-2021-03916
• Device Sequence Number: 4440530
• Product Code: LWS
• UDI-Device Identifier: 04035479125530
• UDI-Public: 04035479125530
• Combination Product (Y/N): N
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2016
• Device Model Number: 383597
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Initial Date Received by Manufacturer: 07/11/2021
• Supplement Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization