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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LINOX SMART T 65; ICD LEAD
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BIOTRONIK SE & CO. KG LINOX SMART T 65; ICD LEAD Back to Search Results
Model Number 369820
Medical Device Problem Codes Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code Shock from Patient Lead(s) (3162)
Date of Event 12/21/2020
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported after approx.86 months implantation time, that the patient received inappropriate shocks due to oversensing.The lead is in the patient and if explanted, it will be returned for analysis.The patient was hospitalized and therapy was set to off.
 
Additional Manufacturer Narrative
The provided x-ray image shows 4 implanted leads.An interaction with the nearby leads as well an an interaction to the generator housing cannot be excluded.There is no other data available for further investigation.
 
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Brand Name
LINOX SMART T 65
Common Device Name
ICD LEAD
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin 12359
MDR Report Key11113483
Report Number1028232-2021-00037
Device Sequence Number19820977
Product Code NVY
UDI-Device Identifier04035479112998
UDI-Public04035479112998
Combination Product (Y/N)N
PMA/510(K) Number
P980023
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 12/25/2020
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 Date12/31/2014
Device Model Number369820
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 01/04/2021
Supplement Date Received by Manufacturer06/23/2021
Initial Report FDA Received Date01/04/2021
Supplement Report FDA Received Date06/28/2021
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;
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