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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LUMAX 340 HF-T; CRT-D
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BIOTRONIK SE & CO. KG LUMAX 340 HF-T; CRT-D Back to Search Results
Model Number 355263
Device Problem Premature End-of-Life Indicator (1480)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/19/2020
Event Type  malfunction  
Event Description
Device explanted due to eos.No adverse patient events reported.Should additional information become available, this file will be updated.
 
Manufacturer Narrative
We received your event description for the above mentioned device and would like to thank you for supporting our post-market surveillance.As of today, the medical device is not available for analysis, therefore the device itself could not be investigated.The information you provided has been entered into our quality system as a complaint.These types of complaints are used to evaluate systems and device performance throughout our organization and help to maintain and improve the performance of our devices.Should additional relevant information or the device itself become available, the investigation will be updated.
 
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Brand Name
LUMAX 340 HF-T
Type of Device
CRT-D
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin 12359
MDR Report Key10925175
MDR Text Key219358187
Report Number1028232-2020-05208
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 11/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number355263
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Date Manufacturer Received12/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age81 YR
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