Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE; PERMANENT DEFIBRILLATOR ELECTRODES
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE; PERMANENT DEFIBRILLATOR ELECTRODES Back to Search Results
Model Number 0266
Medical Device Problem Code Defective Device (2588)
Health Effect - Clinical Codes Ventricular Tachycardia (2132); Heart Failure (2206)
Date of Event 07/05/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
 
Event or Problem Description
It was reported that this patient with an implantable cardioverter defibrillator (icd) underwent a tricuspid valve repair.The device was surgically abandoned.No additional adverse patient effects were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ENDOTAK RELIANCE
Common Device Name
PERMANENT DEFIBRILLATOR ELECTRODES
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
MDR Report Key9270139
Report Number2124215-2019-23118
Device Sequence Number19457540
Product Code NVY
UDI-Device Identifier00802526431296
UDI-Public00802526431296
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/02/2019
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 Health Professional
Device Expiration Date09/19/2016
Device Model Number0266
Device Catalogue Number0266
Device Lot Number308252
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/16/2019
Initial Report FDA Received Date11/02/2019
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; Life Threatening; Required Intervention;
Patient Age77 YR
-
-