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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RELIANCE 4-FRONT; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

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BOSTON SCIENTIFIC CORPORATION RELIANCE 4-FRONT; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) Back to Search Results
Model Number 0672
Device Problems Failure to Capture (1081); Positioning Problem (3009)
Patient Problem Cardiac Arrest (1762)
Event Date 04/13/2023
Event Type  Injury  
Event Description
It was reported that this patient underwent a coronary artery graft procedure, and a few days later a procedure to implant an implantable cardioverter defibrillator (icd) was attempted.Temporary pacing wires and a temporary external pacemaker were utilized.The device pocket was created, and the subclavian vein was accessed with a stylet.The physician experienced difficulty accessing the right ventricle (rv), and despite efforts to re-shape the stylet, it could not be placed into the lead and a second stylet was presented.The physician still had an unused firm and a soft stylet but the boston scientific sales representative who was present at the procedure went to the stock room to obtain additional stylets for back up use.The representative returned with the stylets and observed that the lead was not in the rv and the patient was in cardiac arrest.The lead was placed in the rv and connected to the pacing system analyzer (psa) cables.Pacing spikes were observed on the electrograms which correlated with the psa; however, capture was unsuccessful despite maximum outputs.External pacing was unsuccessful and cardiac massage was required.The patient was put on a bypass machine and then an extracorporeal membrane oxygenation (ecmo) machine and transferred back to the intensive care unit.No additional adverse patient effects were reported.
 
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.
 
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Brand Name
RELIANCE 4-FRONT
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
road 698, lot no. 12
dorado PR 00646 -260
*   00646-2602
Manufacturer Contact
timothy degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key16772544
MDR Text Key313610253
Report Number2124215-2023-18720
Device Sequence Number1
Product Code LWS
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/19/2023
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
Device Operator Health Professional
Device Model Number0672
Device Catalogue Number0672
Device Lot Number206469
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/13/2023
Initial Date FDA Received04/19/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/16/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Other; Life Threatening; Hospitalization;
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