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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ILESTO 7 DR-T DF-1 US; ICD
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BIOTRONIK SE & CO. KG ILESTO 7 DR-T DF-1 US; ICD Back to Search Results
Model Number 383562
Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Ambient Noise Problem (2877)
Patient Problem Shock from Patient Lead(s) (3162)
Event Date 10/30/2018
Event Type  Injury  
Event Description
Noise detected on all channels suggesting external source.Patient received inappropriate therapy.The device remains implanted.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
ILESTO 7 DR-T DF-1 US
Type of Device
ICD
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin D-123 59
GM  D-12359
MDR Report Key8052290
MDR Text Key126576294
Report Number1028232-2018-03862
Device Sequence Number1
Product Code MRM
Combination Product (y/n)N
PMA/PMN Number
P050023
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 10/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number383562
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Date Manufacturer Received11/15/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age86 YR
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