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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LINOX SMART S 60; ICD LEAD
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BIOTRONIK SE & CO. KG LINOX SMART S 60; ICD LEAD Back to Search Results
Model Number 375012
Medical Device Problem Codes Fracture (1260); Low impedance (2285); Ambient Noise Problem (2877)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/23/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that this lead was capped due to fracture causing noise on the rv channel.A decrease in shock impedance was also noticed at the beginning of june 2021.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
LINOX SMART S 60
Common Device Name
ICD LEAD
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin 12359
MDR Report Key12096344
Report Number1028232-2021-03664
Device Sequence Number4166128
Product Code NVY
UDI-Device Identifier04035479116194
UDI-Public04035479116194
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P980023
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2012
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 06/25/2021
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 Model Number375012
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/25/2021
Supplement Date Received by Manufacturer07/05/2021
Initial Report FDA Received Date06/30/2021
Supplement Report FDA Received Date07/07/2021
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 Age61 YR
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