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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE SG; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
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BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE SG; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) Back to Search Results
Model Number 0182
Medical Device Problem Codes High impedance (1291); Device Sensing Problem (2917); High Capture Threshold (3266)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 11/01/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.(b)(4).
 
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited high threshold measurements, noise and variability in pacing impedance measurements.The lead was explanted during a routine device replacement procedure.No adverse patient effects were reported.
 
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Brand Name
ENDOTAK RELIANCE SG
Common Device Name
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key9612078
Report Number2124215-2020-00976
Device Sequence Number2721511
Product Code LWS
UDI-Device Identifier00802526531163
UDI-Public00802526531163
Combination Product (Y/N)N
Initial Reporter CountryAS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2009
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/21/2020
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 Date08/15/2010
Device Model Number0182
Device Catalogue Number0182
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/18/2019
Initial Report FDA Received Date01/21/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Other; Required Intervention;
Patient Age27 YR
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