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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 Problem Premature Discharge of Battery (1057)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/19/2021
Event Type  malfunction  
Event Description
It was reported that the battery of this subcutaneous implantable cardioverter defibrillator (s-icd) was prematurely depleting.No intervention has been performed yet and the s-icd remains implanted and in service.No adverse patient effects were reported.Additional information provided from the field indicated the s-icd was programmed off and will remain in situ in the patient.Again, no adverse patient effects were reported.
 
Event Description
It was reported that the battery of this subcutaneous implantable cardioverter defibrillator (s-icd) was prematurely depleting.No intervention has been performed yet and the s-icd remains implanted and in service.No adverse patient effects were reported.Additional information provided from the field indicated the s-icd was programmed off and will remain in situ in the patient.Again, 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 Key11356366
MDR Text Key233025027
Report Number2124215-2021-03795
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 company representative,foreig
Type of Report Initial,Followup
Report Date 04/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date09/28/2018
Device Model NumberA209
Device Catalogue NumberA209
Device Lot Number119221
Was Device Available for Evaluation? No
Date Manufacturer Received02/22/2021
Patient Sequence Number1
Patient Age61 YR
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