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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); Over-Sensing (1438); Pocket Stimulation (1463); Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problems Device Overstimulation of Tissue (1991); Electric Shock (2554)
Event Date 04/01/2021
Event Type  Injury  
Event Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) and electrode exhibited oversensing of noise that resulted in delivery of an inappropriate shock.Technical services (ts) reviewed the stored episode and discussed the noise appeared consistent with myopotentials.The noise was able to be reproduced in all three programmed sensing vectors.The device was programmed off and the physician planned to explant this system and implant a new system.This device remains in service.No additional adverse patient effects were reported.To date, a procedure has not been scheduled.The local area sales representative was contacted for additional information.At this time, no further information is available.Should additional information become available this report will be updated.
 
Event Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) and electrode exhibited oversensing of noise that resulted in delivery of an inappropriate shock.Technical services (ts) reviewed the stored episode and discussed the noise appeared consistent with myopotentials.The noise was able to be reproduced in all three programmed sensing vectors.The device was programmed off and the physician planned to explant this system and implant a new system.This device remains in service.No additional adverse patient effects were reported.To date, a procedure has not been scheduled.The local area sales representative was contacted for additional information.At this time, no further information is available.Should additional information become available this report will be updated.It was reported that inappropriate shock therapy was again delivered due to continued oversensing.Additionally, the patient experienced muscle/pocket stimulation.Surgical intervention was undertaken.The device and electrode were explanted and replaced.No additional adverse patient effects were reported.The return of the product is not expected at this time.The product has been received for analysis.This report will be updated upon completion of analysis.
 
Event Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) and electrode exhibited oversensing of noise that resulted in delivery of an inappropriate shock.Technical services (ts) reviewed the stored episode and discussed the noise appeared consistent with myopotentials.The noise was able to be reproduced in all three programmed sensing vectors.The device was programmed off and the physician planned to explant this system and implant a new system.This device remains in service.No additional adverse patient effects were reported.To date, a procedure has not been scheduled.The local area sales representative was contacted for additional information.At this time, no further information is available.Should additional information become available this report will be updated.It was reported that inappropriate shock therapy was again delivered due to continued oversensing.Additionally, the patient experienced muscle/pocket stimulation.Surgical intervention was undertaken.The device and electrode were explanted and replaced.No additional adverse patient effects were reported.The return of the product is not expected at this time.
 
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 this subcutaneous implantable cardioverter defibrillator (s-icd) and electrode exhibited oversensing of noise that resulted in delivery of an inappropriate shock.Technical services (ts) reviewed the stored episode and discussed the noise appeared consistent with myopotentials.The noise was able to be reproduced in all three programmed sensing vectors.The device was programmed off and the physician planned to explant this system and implant a new system.This device remains in service.No additional adverse patient effects were reported.To date, a procedure has not been scheduled.The local area sales representative was contacted for additional information.At this time, no further information is available.Should additional information become available this report will be updated.It was reported that inappropriate shock therapy was again delivered due to continued oversensing.Additionally, the patient experienced muscle/pocket stimulation.Surgical intervention was undertaken.The device and electrode were explanted and replaced.No additional adverse patient effects were reported.The return of the product is not expected at this time.The product has been received for analysis.This report will be updated upon completion of analysis.
 
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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 Key12112302
MDR Text Key260029316
Report Number2124215-2021-10868
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,Followup,Followup
Report Date 09/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date11/06/2020
Device Model NumberA219
Device Catalogue NumberA219
Device Lot Number237577
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/24/2021
Date Manufacturer Received07/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age56 YR
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