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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 11/30/2023
Event Type  malfunction  
Event Description
This device shows eos.Device remains implanted.No adverse patient events were reported.Should additional information become available, 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 Key18245901
MDR Text Key329478646
Report Number1028232-2023-06082
Device Sequence Number1
Product Code NIK
UDI-Device Identifier04035479156770
UDI-Public(01)04035479156770(17)210731
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 12/04/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2021
Device Model Number429532
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/04/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/29/2019
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 Age59 YR
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