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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN MINI ICD VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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BOSTON SCIENTIFIC CORPORATION DYNAGEN MINI ICD VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number D021
Medical Device Problem Code Defective Device (2588)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 02/06/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This investigation will be updated should further pertinent information be provided.
 
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) device was explanted at a surgical intervention due to unknown product performance issues.No additional adverse patient effects reported.
 
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Brand Name
DYNAGEN MINI ICD VR
Common Device Name
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key11774870
Report Number2124215-2021-12239
Device Sequence Number4331326
Product Code LWS
UDI-Device Identifier00802526533884
UDI-Public00802526533884
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
P960040/S306
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/04/2021
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
Operator of Device Lay User/Patient
Device Expiration Date11/06/2019
Device Model NumberD021
Device Catalogue NumberD021
Device Lot Number107596
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/22/2021
Initial Report FDA Received Date05/05/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age31 YR
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