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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE; PERMANENT DEFIBRILLATOR ELECTRODES
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BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE; PERMANENT DEFIBRILLATOR ELECTRODES Back to Search Results
Model Number 0266
Medical Device Problem Codes Pacing Problem (1439); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 06/07/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(6).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 right ventricular (rv) lead was surgically repositioned due to micro dislodgement which caused the pacing to not be delivered when required.The rv lead remains in service.No additional adverse patient effects were reported.
 
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Brand Name
ENDOTAK RELIANCE
Common Device Name
PERMANENT DEFIBRILLATOR ELECTRODES
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key8847614
Report Number2124215-2019-15232
Device Sequence Number2730658
Product Code NVY
UDI-Device Identifier00802526431296
UDI-Public00802526431296
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/31/2019
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 Lay User/Patient
Device Expiration Date02/19/2021
Device Model Number0266
Device Catalogue Number0266
Device Lot Number420054
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/07/2019
Initial Report FDA Received Date07/31/2019
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 Age55 YR
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