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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ORIGEN MINI ICD VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
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BOSTON SCIENTIFIC CORPORATION ORIGEN MINI ICD VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) Back to Search Results
Model Number D001
Medical Device Problem Codes Premature Discharge of Battery (1057); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 12/14/2018
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (non-crt) recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.This implantable cardioverter defibrillator (non-crt) based on the information received is still in service.An update will be provided in the final report.There were no adverse patient effects.
 
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Brand Name
ORIGEN MINI ICD VR
Common Device Name
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key8268842
Report Number2124215-2019-00633
Device Sequence Number16664562
Product Code LWS
UDI-Device Identifier00802526533723
UDI-Public00802526533723
Combination Product (Y/N)N
Initial Reporter CountryTU
PMA/510(K) Number
P960040/S306
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/22/2019
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
Operator of Device Lay User/Patient
Device Expiration Date03/21/2018
Device Model NumberD001
Device Catalogue NumberD001
Device Lot Number103935
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/17/2018
Initial Report FDA Received Date01/22/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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