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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 Signal Artifact/Noise (1036); High impedance (1291); Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591); Connection Problem (2900); Device Sensing Problem (2917)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/12/2019
Event Type  Injury  
Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed.Visual inspection identified no anomalies.The device was able to be interrogated and a memory download was performed successfully.The device produced audible tones in the presence of a magnet.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.Simulated induction testing was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.
 
Event Description
It was reported that after device implant, the device exhibited high out of range impedance.Imaging was performed which displayed an incomplete pin insertion.The patient was brought back for a revision procedure two days after implant.Attempts to fully insert the electrode into the header failed, so the physician elected to implant a new device that the original electrode was able to fully insert into.Measurement and impedance testing was successful.The device was returned for analysis.No additional adverse patient effects were reported.
 
Event Description
This supplemental report is being filled to include device analysis information.
 
Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed.Visual inspection identified no anomalies.The device was able to be interrogated and a memory download was performed successfully.The device produced audible tones in the presence of a magnet.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.Simulated induction testing was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.
 
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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 Key9602944
MDR Text Key175437835
Report Number2124215-2019-28297
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? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberA219
Device Catalogue NumberA219
Device Lot Number253286
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/21/2019
Initial Date Manufacturer Received 11/12/2019
Initial Date FDA Received01/17/2020
Supplement Dates Manufacturer Received03/19/2020
Supplement Dates FDA Received04/10/2020
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention;
Patient Age57 YR
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