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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ORIGEN MINI ICD DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
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BOSTON SCIENTIFIC CORPORATION ORIGEN MINI ICD DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) Back to Search Results
Model Number D002
Medical Device Problem Codes High impedance (1291); Noise, Audible (3273)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 06/27/2019
Type of Reportable Event Malfunction
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) was beeping due to a high out of range pacing impedance measurement of greater than 2000 ohms on the right atrial channel.No changes have been made and the icd remains in service.No adverse patient effects were reported.
 
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Brand Name
ORIGEN 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 Key8876082
Report Number2124215-2019-17281
Device Sequence Number11360454
Product Code LWS
UDI-Device Identifier00802526533747
UDI-Public00802526533747
Combination Product (Y/N)N
Initial Reporter CountryGM
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) 08/08/2019
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 Date07/05/2018
Device Model NumberD002
Device Catalogue NumberD002
Device Lot Number109316
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 Date08/08/2019
Patient Sequence Number1
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