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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 Failure to Capture (1081); Over-Sensing (1438)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 01/29/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The lead is currently not available for analysis.No conclusion can be drawn based on available information at the moment.The file is closed.The investigation will be re-opened should additional data become available.
 
Event or Problem Description
After an implantation period of approx.114 months, oversensing in the ventricular channel was reported during a follow-up.It was observed that the alerts were due to loss of capture.No adverse patient side effects have been reported.
 
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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
DE  12359
MDR Report Key11593302
Report Number1028232-2021-01503
Device Sequence Number3511568
Product Code NVY
UDI-Device Identifier04035479112998
UDI-Public04035479112998
Combination Product (Y/N)N
Initial Reporter CountryDE
PMA/510(K) Number
P980023
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2011
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 03/17/2021
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 Expiration Date12/31/2012
Device Model Number369820
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/30/2021
Initial Report FDA Received Date03/30/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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