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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ORIGEN CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
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BOSTON SCIENTIFIC CORPORATION ORIGEN CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D Back to Search Results
Model Number G050
Medical Device Problem Code Premature Discharge of Battery (1057)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 09/28/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Following return and completion of laboratory analysis, this event will be further updated.
 
Event or Problem Description
It was reported that this device was explanted with suspected premature battery depletion however it was known/reported that the left ventricular lead had been programmed with high outputs.The explanted unit is expected to be returned for analysis and no other adverse patient effects were reported.
 
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Brand Name
ORIGEN CRT-D
Common Device Name
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key10667693
Report Number2124215-2020-20389
Device Sequence Number3581163
Product Code NIK
UDI-Device Identifier00802526534454
UDI-Public00802526534454
Combination Product (Y/N)N
Initial Reporter CountryLE
PMA/510(K) Number
P010012/S341
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/12/2020
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 Date08/31/2018
Device Model NumberG050
Device Catalogue NumberG050
Device Lot Number483534
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/28/2020
Initial Report FDA Received Date10/12/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Life Threatening;
Patient Age58 YR
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