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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM S-ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
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BOSTON SCIENTIFIC CORPORATION EMBLEM S-ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) Back to Search Results
Model Number A209
Device Problems Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem Atrial Tachycardia (1731)
Event Date 11/19/2019
Event Type  malfunction  
Manufacturer Narrative
This investigation is ongoing.Upon additional information this investigation will be updated.
 
Event Description
It was reported that an inappropriate shock was delivered due to a fast irregular arrhythmia.A review by technical services (ts) noted that the fast rhythm observed occurred due to a fast conducted atrial tachyarrhythmia.It was noted that the device was reprogrammed from secondary to primary vector.Ts discussed performing in office troubleshooting for further testing and sensor optimization.No adverse patient effects were reported.
 
Manufacturer Narrative
This investigation is ongoing.Upon additional information this investigation will be updated.
 
Event Description
It was reported that an inappropriate shock was delivered due to a fast irregular arrhythmia.A review by technical services (ts) noted that the fast rhythm observed occurred due to a fast conducted atrial tachyarrhythmia.It was noted that the device was reprogrammed from secondary to primary vector.Ts discussed performing in office troubleshooting for further testing and sensor optimization.No adverse patient effects were reported.
 
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Brand Name
EMBLEM S-ICD
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key9593646
MDR Text Key175197917
Report Number2124215-2020-00710
Device Sequence Number1
Product Code LWS
UDI-Device Identifier00802526544101
UDI-Public00802526544101
Combination Product (y/n)N
PMA/PMN Number
P110042/S043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 01/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date07/03/2017
Device Model NumberA209
Device Catalogue NumberA209
Device Lot Number105553
Was Device Available for Evaluation? No
Date Manufacturer Received12/19/2019
Patient Sequence Number1
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