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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 Discomfort (2330)
Date of Event 04/05/2021
Type of Reportable Event Serious Injury
Event or Problem Description
System explanted due to pocket discomfort.Should additional information become available, it will be added to this file.
 
Additional Manufacturer Narrative
We received your event description for the above mentioned device and would like to thank you for supporting our post-market surveillance.As of today, the medical device is not available for analysis, therefore the device itself could not be investigated.The information you provided has been entered into our quality system as a complaint.These types of complaints are used to evaluate systems and device performance throughout our organization and help to maintain and improve the performance of our devices.Should additional relevant information or the device itself become available, the investigation will be updated.
 
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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 Key11625114
Report Number1028232-2021-01646
Device Sequence Number4216357
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
Device Explanted Year2021
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 04/05/2021
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 Date10/31/2021
Device Model Number404629
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 04/05/2021
Supplement Date Received by Manufacturer04/07/2021
Initial Report FDA Received Date04/06/2021
Supplement Report FDA Received Date04/09/2021
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 Age77 YR
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