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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM MRI S-ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
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BOSTON SCIENTIFIC CORPORATION EMBLEM MRI S-ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) Back to Search Results
Model Number A219
Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/26/2019
Event Type  malfunction  
Manufacturer Narrative
At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.
 
Event Description
It was reported that interrogation of this subcutaneous implantable cardioverter defibrillator (s-icd) during pre-implant preparation, noted a message indicating a potential product performance issue.The device was not used for implant.Another device was used and successfully implanted.No adverse patient effects were reported.
 
Manufacturer Narrative
The returned device was thoroughly inspected and analyzed.Visual inspection identified no anomalies.The device was able to be interrogated and a memory download was performed successfully.The device was then exposed to simulated heart load conditions, and the defibrillation and sensing functions were tested.The device operated appropriately, according to its performance specifications with no out of range measurements or interruptions in therapy output.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.
 
Event Description
It was reported that interrogation of this subcutaneous implantable cardioverter defibrillator (s-icd) during pre-implant preparation, noted a message indicating a potential product performance issue.The device was not used for implant.Another device was used and successfully implanted.No adverse patient effects were reported.
 
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Brand Name
EMBLEM MRI 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 Key9593513
MDR Text Key175123113
Report Number2124215-2020-00725
Device Sequence Number1
Product Code LWS
UDI-Device Identifier00802526584404
UDI-Public00802526584404
Combination Product (y/n)N
PMA/PMN Number
P110042/S058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 04/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date11/20/2021
Device Model NumberA219
Device Catalogue NumberA219
Device Lot Number256816
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/28/2020
Initial Date Manufacturer Received 12/26/2019
Initial Date FDA Received01/15/2020
Supplement Dates Manufacturer Received02/20/2020
Supplement Dates FDA Received04/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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