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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); Device Dislodged or Dislocated (2923); High Capture Threshold (3266)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/14/2024
Event Type  malfunction  
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 Description
It was reported that an alert had been generated for right ventricular automatic threshold (rvat) detected as greater than programmed amplitude or suspended.Capture could not be confirmed on the presenting electrogram, and stored data identified potential rv loss of capture.Dislodgement of this rv lead is suspected.The physician has not determined a course of action at this time and the lead remains in service.No 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.
 
Event Description
It was reported that an alert had been generated for right ventricular automatic threshold (rvat) detected as greater than programmed amplitude or suspended.Capture could not be confirmed on the presenting electrogram, and stored data identified potential rv loss of capture.Dislodgement of this rv lead is suspected.The physician has not determined a course of action at this time and the lead remains in service.No adverse patient effects were reported.It was reported that defibrillation therapy was programmed off and a lead revision procedure will be scheduled in the near future.No adverse patient effects were reported.
 
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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 Key19214111
MDR Text Key341402340
Report Number2124215-2024-26107
Device Sequence Number1
Product Code LWS
Combination Product (y/n)Y
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/01/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number0672
Device Catalogue Number0672
Device Lot Number226439
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/01/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/25/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Age67 YR
Patient SexFemale
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