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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ILESTO 7 VR-T DF-1; ICD
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BIOTRONIK SE & CO. KG ILESTO 7 VR-T DF-1; ICD Back to Search Results
Model Number 383578
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Pocket Erosion (2013)
Date of Event 02/11/2020
Type of Reportable Event Serious Injury
Event or Problem Description
This system was explanted due to erosion.New upgraded system was implanted same day.Should additional information become available, this file will be updated.Hospital retained system and should return it for analysis.
 
Additional Manufacturer Narrative
An erosion was observed following the implantation of this biotronik device.The sterilization process was investigated.The validated process assures that all sterilization parameters, such as gas concentration, temperature, humidity, etc., are within its specified ranges for each distributed device.Additionally an analysis of validated microbiological indicators is performed after every sterilization procedure as evidence of successful completion of the sterilization process.Review of the biotronik complaint database did not reveal any changes regarding the trend for this type of incident.In conclusion, the erosion was not device related.
 
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Brand Name
ILESTO 7 VR-T DF-1
Common Device Name
ICD
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin 12359
MDR Report Key9717470
Report Number1028232-2020-00787
Device Sequence Number361777
Product Code LWS
UDI-Device Identifier04035479125349
UDI-Public04035479125349
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P050023
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date (Section B) 02/11/2020
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 Model Number383578
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/10/2020
Initial Date Received by Manufacturer 02/11/2020
Supplement Date Received by Manufacturer03/02/2020
04/07/2020
Initial Report FDA Received Date02/17/2020
Supplement Report FDA Received Date03/04/2020
04/08/2020
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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