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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG INTICA 7 HF-T QP DF-1 IS4 PROMRI; CRT-D
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BIOTRONIK SE & CO. KG INTICA 7 HF-T QP DF-1 IS4 PROMRI; CRT-D Back to Search Results
Model Number 404629
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 06/03/2021
Type of Reportable Event Serious Injury
Event or Problem Description
Device explanted due to infection.Explant date is unknown.Should additional information become available, it will be added to this file.
 
Additional Manufacturer Narrative
An infection was observed following the implantation of this biotronik device.The sterilization process was investigated.The validated process assures that all sterilization parameters, such as gas concentration, temperature, humidity, etc., are within its specified ranges for each distributed device.Additionally an analysis of validated microbiological indicators is performed after every sterilization procedure as evidence of successful completion of the sterilization process.Review of the biotronik complaint database did not reveal any changes regarding the trend for this type of incident.In conclusion, the infection was not device related.
 
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Brand Name
INTICA 7 HF-T QP DF-1 IS4 PROMRI
Common Device Name
CRT-D
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin 12359
MDR Report Key11950074
Report Number1028232-2021-03175
Device Sequence Number1060861
Product Code NIK
UDI-Device Identifier04035479142162
UDI-Public04035479142162
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P050023
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 06/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date05/31/2020
Device Model Number404629
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2021
Initial Date Received by Manufacturer 06/03/2021
Supplement Date Received by Manufacturer06/08/2021
Initial Report FDA Received Date06/07/2021
Supplement Report FDA Received Date06/15/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization;
Patient Age76 YR
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