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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 0263
Medical Device Problem Code No Apparent Adverse Event (3189)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 02/24/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that this right ventricular lead was explanted due to unknown product performance issue.Reasonable evidence suggests this lead exhibited a malfunction.This lead was successfully replaced.No additional adverse patient effects were reported.Attempts to obtain additional information were unsuccessful.
 
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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 Key11662259
Report Number2124215-2021-06582
Device Sequence Number11445690
Product Code NVY
UDI-Device Identifier00802526601835
UDI-Public00802526601835
Combination Product (Y/N)Y
Initial Reporter StateOR
Initial Reporter CountryUS
PMA/510(K) Number
P910073/S077
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/13/2021
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 Date12/18/2020
Device Model Number0263
Device Catalogue Number0263
Device Lot Number100012
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/24/2021
Initial Report FDA Received Date04/13/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age58 YR
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