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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 Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Unspecified Infection (1930); No Code Available (3191)
Date of Event 10/12/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.(b)(4).The lead was returned.No analysis was performed as reported allegation of infection was known inherent risk of device.
 
Event or Problem Description
It was reported that this implantable lead was part of a system revision due to infection.There were no additional adverse patient effects reported.The implantable lead was explanted.
 
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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 Key11040322
Report Number2124215-2020-26080
Device Sequence Number16442493
Product Code LWS
UDI-Device Identifier00802526531163
UDI-Public00802526531163
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2011
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/18/2020
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? No
Operator of Device Lay User/Patient
Device Expiration Date12/09/2011
Device Model Number0182
Device Catalogue Number0182
Device Lot Number300101
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/27/2020
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/12/2020
Initial Report FDA Received Date12/18/2020
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; Required Intervention;
Patient Age76 YR
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