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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 Signal Artifact/Noise (1036); Failure to Capture (1081); Mechanical Problem (1384); Impedance Problem (2950); High Capture Threshold (3266)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/12/2024
Event Type  malfunction  
Event Description
It was reported that this right ventricular (rv) lead was unable to be implanted due to high thresholds, noise, loss of capture and impedance issues.This lead was also noted to have exhibited helix extension issues.This lead was successfully replaced and is expected to be returned for analysis.No adverse patient effects were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 Key19009377
MDR Text Key338988901
Report Number2124215-2024-19282
Device Sequence Number1
Product Code LWS
Combination Product (y/n)Y
Reporter Country CodePO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 03/31/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0672
Device Catalogue Number0672
Device Lot Number235269
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/12/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/16/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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