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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG RIVACOR 7 HF-T QP DF4 IS4 PROMRI; CRT-D
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BIOTRONIK SE & CO. KG RIVACOR 7 HF-T QP DF4 IS4 PROMRI; CRT-D Back to Search Results
Model Number 429532
Device Problem Premature End-of-Life Indicator (1480)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/19/2024
Event Type  malfunction  
Event Description
Device was explanted and replaced due to eos.No adverse patient events reported.Should additional information be received, this file will be updated.
 
Manufacturer Narrative
The device is currently not available for analysis.No conclusion can be drawn based on available information at the moment.The file is closed.The investigation will be re-opened should additional data become available.
 
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Brand Name
RIVACOR 7 HF-T QP DF4 IS4 PROMRI
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 Key18977882
MDR Text Key338588024
Report Number1028232-2024-01640
Device Sequence Number1
Product Code NIK
UDI-Device Identifier04035479156770
UDI-Public(01)04035479156770(17)221130
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P050023
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/03/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2022
Device Model Number429532
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/03/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/25/2020
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;
Patient Age35 YR
Patient SexMale
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