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U.S. Department of Health and Human Services

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

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BIOTRONIK SE & CO. KG IFORIA 3 HF-T DF4; CRT-D Back to Search Results
Model Number 383556
Device Problem Premature End-of-Life Indicator (1480)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/20/2021
Event Type  malfunction  
Event Description
It was reported that the device was explanted due to eos status approx.81 months after the implantation.Please note this icd is affected by a field safety corrective action, bio-lqc, initiated in march 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.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 with an attached external power supply 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.
 
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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 Key12158869
MDR Text Key261255484
Report Number1028232-2021-03915
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
PMA/PMN Number
P050023
Number of Events Reported1
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 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
Device Operator Health Professional
Device Expiration Date08/31/2015
Device Model Number383556
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/29/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/11/2021
Initial Date FDA Received07/13/2021
Supplement Dates Manufacturer Received11/05/2021
Supplement Dates FDA Received11/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/19/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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