MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG IFORIA 5 HF-T PROMRI DF4; CRT-D

Model Number 390113

Device Problem Premature End-of-Life Indicator (1480)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/21/2021

Event Type  malfunction  

Event Description

After an implantation period of approx.53 months, it was reported that the device shows the eos status.The icd was explanted.Please note this icd is affected by a field safety corrective action, bio-lqc, initiated in (b)(6) 2021.

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.The device interrogation revealed the eos battery status, detected on (b)(6) 2021.The device was implanted for 52 months and 17 charging cycles were recorded in the devices memory.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 an 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 HF-T PROMRI DF4
• Type of Device: CRT-D
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 12298420
• MDR Text Key: 265812061
• Report Number: 1028232-2021-04481
• Device Sequence Number: 1
• Product Code: NIK
• 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: 08/03/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: 390113
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Initial Date Manufacturer Received: 08/09/2021
• Initial Date FDA Received: 08/09/2021
• Supplement Dates Manufacturer Received: 10/12/2021
• Supplement Dates FDA Received: 10/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization