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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AUTOGEN; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
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BOSTON SCIENTIFIC CORPORATION AUTOGEN; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) Back to Search Results
Model Number D174
Device Problems Premature Discharge of Battery (1057); Device Displays Incorrect Message (2591)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/20/2023
Event Type  Injury  
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 device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Data analysis showed the battery appeared to be depleting more quickly than expected.Device replacement was recommended.This device remains implanted at this time.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.
 
Event Description
It was reported that this device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Data analysis showed the battery appeared to be depleting more quickly than expected.Device replacement was recommended.This device remains implanted at this time.No adverse patient effects were reported.Additional information was received that this device was subsequently explanted and replaced.No additional adverse patient effects were reported.
 
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Brand Name
AUTOGEN
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
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 Key17434786
MDR Text Key320160620
Report Number2124215-2023-40687
Device Sequence Number1
Product Code LWS
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
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 Received08/01/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date08/21/2017
Device Model NumberD174
Device Catalogue NumberD174
Device Lot Number197494
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/21/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/21/2015
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age37 YR
Patient SexMale
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