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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AUTOGEN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
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BOSTON SCIENTIFIC CORPORATION AUTOGEN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D Back to Search Results
Model Number G175
Device Problems Failure to Select Signal (1582); Low impedance (2285)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/04/2019
Event Type  malfunction  
Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
 
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) detected a sudden decrease in shock impedances.The r-wave amplitudes have also reduced some.Additional information received indicates that the values returned to normal and no intervention is planned.The device remains in service.No adverse patient effects were reported.
 
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Brand Name
AUTOGEN
Type of Device
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
Manufacturer (Section G)
BOSTON SCIENTIFIC CLONMEL LIMITED
cashel road
,
clonmel
EI  
Manufacturer Contact
timothy degroot
4100 hamline avenue north
,
saint paul, MN 55112
6515826168
MDR Report Key8778037
MDR Text Key150624515
Report Number2124215-2019-08812
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberG175
Device Catalogue NumberG175
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/04/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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