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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); High impedance (1291); High Capture Threshold (3266)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/05/2021
Event Type  malfunction  
Event Description
It was reported that during the implant procedure prior to wound closure, this right ventricular (rv) lead exhibited high, out of range pacing impedance measurements (4000 ohms).A high capture threshold measurement and loss of capture was also observed.The physician elected to exchange the rv lead to resolve the event.The patient was stable with no adverse consequences.The rv lead is expected for analysis, but has not yet been received.
 
Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.Visual inspection revealed a deformed helix consistent with procedural damage.Testing was completed to assess lead electrical performance and inner/outer insulation integrity.Measurements throughout these tests were within normal limits.Microscopic inspections of the terminal pin assembly, lead body, and electrode tip found no anomalies.Laboratory testing was unable to reproduce the reported clinical observations and detailed analysis did not reveal any abnormalities.Laboratory analysis did not identify any lead characteristics that would have caused or contributed to the reported clinical observations.
 
Event Description
It was reported that during the implant procedure prior to wound closure, this right ventricular (rv) lead exhibited high, out of range pacing impedance measurements (4000 ohms).A high capture threshold measurement and loss of capture was also observed.The physician elected to exchange the rv lead to resolve the event.The patient was stable with no adverse consequences.The rv lead was received for analysis.
 
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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
MDR Report Key11355281
MDR Text Key232816398
Report Number2124215-2021-02452
Device Sequence Number1
Product Code LWS
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/03/2022
Device Model Number0672
Device Catalogue Number0672
Device Lot Number125118
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/23/2021
Date Manufacturer Received04/19/2021
Patient Sequence Number1
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