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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN MINI ICD DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
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BOSTON SCIENTIFIC CORPORATION INOGEN MINI ICD DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) Back to Search Results
Model Number D013
Medical Device Problem Code Migration (4003)
Health Effect - Clinical Code Pain (1994)
Date of Event 06/27/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
 
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) device was explanted due to unknown product performance issue.Additional information obtained from the field which indicated that the device migrated down into the breast tissues causing a painful sensation to the patient.The physician performed a pocket revision and elected to replace the battery.No additional adverse patient effects were reported.
 
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Brand Name
INOGEN MINI ICD DR
Common Device Name
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key8819664
Report Number2124215-2019-14471
Device Sequence Number3272733
Product Code LWS
UDI-Device Identifier00802526533846
UDI-Public00802526533846
Combination Product (Y/N)N
Initial Reporter StateGA
Initial Reporter CountryUS
PMA/510(K) Number
P960040/S306
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/23/2019
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 Date06/12/2016
Device Model NumberD013
Device Catalogue NumberD013
Device Lot Number102168
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/27/2019
Initial Report FDA Received Date07/23/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Life Threatening; Required Intervention;
Patient Age52 YR
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