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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RELIANCE 4-FRONT; IMPLANTABLE LEAD
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BOSTON SCIENTIFIC CORPORATION RELIANCE 4-FRONT; IMPLANTABLE LEAD Back to Search Results
Model Number 0673
Device Problems Failure to Capture (1081); High impedance (1291); Defective Device (2588); Device Sensing Problem (2917); High Capture Threshold (3266)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/04/2023
Event Type  malfunction  
Event Description
It was reported that during an implant this right ventricular (rv) lead was implanted in the rv chamber but started showing qrs wave sensing issues.Also, loss of capture (loc) was observed at high outputs and pacing impedance was high, out of range.The rv lead was repositioned with the same electrical measurements.A new pacing system analyzer (psa) disposable cable was used, psa extension cord, and a separate psa were used in different attempts, with the same findings.Also, connection with alligator clips, reseating ez tool, connecting without tool and testing unipolar did not resolve issue.The lead was explanted as a lead damage or integrity issue was suspected.A second lead was opened and implanted without incident and normal electrical measurements.The explanted lead is being returned for analysis and reporting.No additional adverse patient effects were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during an implant this right ventricular (rv) lead was implanted in the rv chamber but started showing qrs wave sensing issues.Also, loss of capture (loc) was observed at high outputs and pacing impedance was high, out of range.The rv lead was repositioned with the same electrical measurements.A new pacing system analyzer (psa) disposable cable was used, psa extension cord, and a separate psa were used in different attempts, with the same findings.Also, connection with alligator clips, reseating ez tool, connecting without tool and testing unipolar did not resolve issue.The lead was explanted as a lead damage or integrity issue was suspected.A second lead was opened and implanted without incident and normal electrical measurements.The explanted lead is being returned for analysis and reporting.No additional adverse patient effects were reported.
 
Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.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.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 LEAD
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 Key16805584
MDR Text Key313900755
Report Number2124215-2023-19700
Device Sequence Number1
Product Code LWS
UDI-Device Identifier00802526592867
UDI-Public00802526592867
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0673
Device Catalogue Number0673
Device Lot Number189602
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/12/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/04/2023
Initial Date FDA Received04/25/2023
Supplement Dates Manufacturer Received07/18/2023
Supplement Dates FDA Received07/20/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/18/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age74 YR
Patient SexFemale
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