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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 0672
Device Problems Failure to Capture (1081); Fracture (1260); High impedance (1291); High Capture Threshold (3266)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/02/2024
Event Type  malfunction  
Event Description
It was reported that this right ventricular (rv) lead was an attempted implant as after repositioning it, exhibited high out of range pacing impedance and high pacing threshold measurements, along with loss of capture.Lead conductor fracture is suspected.A different lead was used, and the procedure was completed successfully.No adverse patient effects were reported.The attempted lead is expected to be returned for analysis.
 
Manufacturer Narrative
At this time, the product has not been returned.If the product is returned, analysis will be performed, and this report will be updated at that time.
 
Event Description
It was reported that this right ventricular (rv) lead was an attempted implant as after repositioning it, exhibited high out of range pacing impedance and high pacing threshold measurements, along with loss of capture.Lead conductor fracture is suspected.A different lead was used, and the procedure was completed successfully.No adverse patient effects were reported.The attempted lead is expected to be returned for analysis.
 
Manufacturer Narrative
At this time, the product has not been returned.If the product is returned, analysis will be performed, and this report will be updated at that time.
 
Event Description
It was reported that this right ventricular (rv) lead was an attempted implant as after repositioning it, exhibited high out of range pacing impedance and high pacing threshold measurements, along with loss of capture.Lead conductor fracture is suspected.A different lead was used, and the procedure was completed successfully.No adverse patient effects were reported.The attempted lead was returned for analysis.
 
Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.Visual inspection found dried blood/body fluid in the helix housing, but no abnormalities or evidence of damage were identified.Testing was completed to assess lead electrical performance and inner insulation integrity.Measurements throughout these tests were within normal limits.Additionally, a stylet insertion test was performed and passed without problems, indicating no blockage in the lumen.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.
 
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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 Key18757794
MDR Text Key336868945
Report Number2124215-2024-10570
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,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 05/02/2024
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 Number0672
Device Catalogue Number0672
Device Lot Number224559
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/02/2024
Initial Date FDA Received02/22/2024
Supplement Dates Manufacturer Received03/06/2024
04/29/2024
Supplement Dates FDA Received03/08/2024
05/02/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/14/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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