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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 Device Dislodged or Dislocated (2923); High Capture Threshold (3266)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/15/2020
Type of Reportable Event Malfunction
Event or Problem Description
Device interrogation on (b)(6) 2020 showed high lead thresholds.Lead was found to be dislodged, and patient underwent revision on (b)(6) 2020.No adverse patient events were reported.Should additional information be received, 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 Key10590809
Report Number1028232-2020-04095
Device Sequence Number2822794
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
Reporter Type Manufacturer
Report Source company representative,study
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 09/21/2020
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? Yes
Operator of Device Health Professional
Device Expiration Date05/31/2022
Device Model Number395722
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 09/21/2020
Supplement Date Received by Manufacturer10/08/2020
Initial Report FDA Received Date09/25/2020
Supplement Report FDA Received Date10/08/2020
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 Age80 YR
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