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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE; IMPLANTABLE LEAD
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BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE; IMPLANTABLE LEAD Back to Search Results
Model Number 0266
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 07/09/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Product is not expected to be returned.No further information concerning this report is available at this time.This investigation will be updated should further pertinent information be provided.(b)(4).
 
Event or Problem Description
It was reported that this right ventricular (rv) lead was explanted due to other/on product experience.This lead remained in service for 15 months and it was explanted along with the pacemaker device.Reasonable evidence suggests this lead exhibited a malfunction.No additional adverse patient effects were reported.
 
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Brand Name
ENDOTAK RELIANCE
Common Device Name
IMPLANTABLE LEAD
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key10616760
Report Number2124215-2020-16900
Device Sequence Number3670316
Product Code NVY
UDI-Device Identifier00802526431296
UDI-Public00802526431296
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/01/2020
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 Date09/25/2020
Device Model Number0266
Device Catalogue Number0266
Device Lot Number419941
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/09/2020
Initial Report FDA Received Date10/01/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age63 YR
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