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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 Problems Inappropriate/Inadequate Shock/Stimulation (1574); Ambient Noise Problem (2877)
Patient Problem Shock from Patient Lead(s) (3162)
Event Date 12/08/2015
Event Type  malfunction  
Event Description
This device was explanted and replaced after the rv lead inappropriately shocked the patient due to noise.The battery had about 25% remaining on it, but due to the patient's anatomy, it was decided a smaller lead and header would work better for this patient.
 
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.
 
Event Description
This device was explanted and replaced after the rv lead inappropriately shocked the patient due to noise.The battery had about 25% remaining on it, but due to the patient's anatomy, it was decided a smaller lead and header would work better for this patient.
 
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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 D-123 59
GM  D-12359
Manufacturer Contact
6024 jean road
lake oswego, OR 97035
8772459800
MDR Report Key5323325
MDR Text Key34261009
Report Number1028232-2015-04590
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P050023
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 12/11/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2015
Is this an Adverse Event Report? Yes
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
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/07/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/19/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age66 YR
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