MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG IFORIA 3 HF-T DF4; CRT-D

Model Number 383556

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

Patient Problem Anxiety (2328)

Event Date 09/14/2021

Event Type  Injury  

Event Description

It was reported that the device was prophylactically explanted and replaced because the patient was anxious.The device is affected by the field safety corrective action, bio-lqc, initiated in march 2021.The icd was implanted and active for approx.83 months.

Manufacturer Narrative

The icd was received for analysis and inspected.Upon receipt, the device was interrogated.The interrogation could be properly performed and revealed the mos2 battery status.All electrical parameters were verified and showed a normal device behavior.Especially, the current consumption and the battery state of discharge were found normal and as expected.There was no indication of a device malfunction.

• Brand Name: IFORIA 3 HF-T DF4
• Type of Device: CRT-D
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 12600551
• MDR Text Key: 275499195
• Report Number: 1028232-2021-05557
• 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: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Model Number: 383556
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization