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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 G179
Device Problems Device Alarm System (1012); High impedance (1291)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/30/2023
Event Type  Injury  
Event Description
It was reported that this implantable device was emitting tones due to an out-of-range shocking impedance measurement.Evaluation noted a gradual rise from 80 ohms to 126 ohms.A boston scientific technical services consultant discussed that a gradual increase in impedance, usually does not indicate a lead fracture but rather a change around the coil and or device.The consultant discussed programming options and further evaluation for this patient.No adverse patient effects were reported.
 
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.
 
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 implantable device was emitting tones due to an out-of-range shocking impedance measurement.Evaluation noted a gradual rise from 80 ohms to 126 ohms.A boston scientific technical services consultant discussed that a gradual increase in impedance, usually does not indicate a lead fracture but rather a change around the coil and or device.The consultant discussed programming options and further evaluation for this patient.No adverse patient effects were reported.Additional information was received that defibrillation threshold (dft) testing was performed due to continued out of range shock impedance measurements.No additional 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 CORPORATION
cashel road
clonmel
EI  
Manufacturer Contact
timothy degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key16376481
MDR Text Key309563733
Report Number2124215-2023-06729
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/27/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date06/12/2020
Device Model NumberG179
Device Catalogue NumberG179
Device Lot Number194210
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/19/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/20/2018
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age60 YR
Patient SexMale
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