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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 Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 02/04/2021
Type of Reportable Event Malfunction
Event or Problem Description
Lv lead dislodged and was explanted.Should additional information become available, it will be added to this file.
 
Additional Manufacturer Narrative
This complaint was opened in error.The complaint on the lv lead was reported in mdr-1028232-2021-00659.This report will be closed.
 
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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 Key11286566
Report Number1028232-2021-00660
Device Sequence Number3846062
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 Year2019
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) 02/04/2021
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? Yes
Operator of Device Health Professional
Device Expiration Date08/31/2019
Device Model Number404629
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 02/04/2021
Supplement Date Received by Manufacturer02/04/2021
Initial Report FDA Received Date02/05/2021
Supplement Report FDA Received Date02/11/2021
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 Age60 YR
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