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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 Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Ambient Noise Problem (2877)
Health Effect - Clinical Code Shock from Patient Lead(s) (3162)
Date of Event 05/31/2021
Type of Reportable Event Serious Injury
Event or Problem Description
Rv lead was capped due to noise.Inappropriate shock delivered and pacing inhibited due to pacer dependency.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 Key11942700
Report Number1028232-2021-03100
Device Sequence Number4176007
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 Year2013
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 05/31/2021
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? Yes
Operator of Device Health Professional
Device Expiration Date09/30/2014
Device Model Number375012
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 05/31/2021
Supplement Date Received by Manufacturer06/04/2021
Initial Report FDA Received Date06/04/2021
Supplement Report FDA Received Date06/15/2021
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 Age75 YR
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