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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG PLEXA S 60; ICD LEAD
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BIOTRONIK SE & CO. KG PLEXA S 60; ICD LEAD Back to Search Results
Model Number 395722
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Cardiac Perforation (2513)
Date of Event 01/05/2021
Type of Reportable Event Serious Injury
Event or Problem Description
The patient was admitted to the hospital with chest pain 12 days after the initial implant.This lead was explanted and replaced due to an rv apex perforation.The revision procedure went well and the patient was doing well the day after revision.Should additional information be received the file will be updated.
 
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.
 
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Brand Name
PLEXA S 60
Common Device Name
ICD LEAD
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin 12359
MDR Report Key11127975
Report Number1028232-2021-00087
Device Sequence Number10934978
Product Code NVY
UDI-Device Identifier04035479133139
UDI-Public04035479133139
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P980023
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
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) 01/05/2021
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 Date10/31/2021
Device Model Number395722
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 01/05/2021
Supplement Date Received by Manufacturer01/07/2021
Initial Report FDA Received Date01/06/2021
Supplement Report FDA Received Date01/11/2021
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 Age74 YR
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