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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG RIVACOR 7 VR-T DX DF4 PROMRI
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BIOTRONIK SE & CO. KG RIVACOR 7 VR-T DX DF4 PROMRI Back to Search Results
Model Number 429535
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Wound Dehiscence (1154)
Date of Event 09/22/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The device is currently not available for analysis.No conclusion can be drawn at this time.No additional information is available at the moment.The file is closed.The investigation will be re-opened should additional data become available.
 
Event or Problem Description
After an implantation period of approximately 29 days, it was reported that a wound dehiscence was observed.Patient brought in and device and lead explanted.
 
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Brand Name
RIVACOR 7 VR-T DX DF4 PROMRI
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin 12359
DE  12359
MDR Report Key12541232
Report Number1028232-2021-05356
Device Sequence Number19156451
Product Code LWS
UDI-Device Identifier04035479156800
UDI-Public04035479156800
Combination Product (Y/N)N
Initial Reporter CountryDE
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2021
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 09/24/2021
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 Date12/31/2022
Device Model Number429535
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/28/2021
Initial Report FDA Received Date09/28/2021
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;
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