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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 Codes High impedance (1291); High Capture Threshold (3266)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 06/11/2020
Type of Reportable Event Malfunction
Event or Problem Description
Lead was explanted and replaced due to high thresholds and impedances.No adverse patient events were reported.Should additional information become available, this 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 Key10155374
Report Number1028232-2020-02428
Device Sequence Number13903320
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 Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 06/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date01/31/2021
Device Model Number395722
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/11/2020
Supplement Date Received by Manufacturer06/17/2020
Initial Report FDA Received Date06/15/2020
Supplement Report FDA Received Date06/19/2020
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 Age69 YR
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