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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 Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/24/2023
Event Type  malfunction  
Manufacturer Narrative
The product has been received for analysis.Upon completion of the failure analysis of the complaint product, if there is any further relevant information from that review, a supplemental report will be filed.
 
Event Description
It was reported that this right ventricular (rv) lead was not implanted successfully due to a bent or kinked.This lead was never in service, and a new lead was placed.No adverse patient effects were reported.
 
Event Description
It was reported that this right ventricular (rv) lead was not implanted successfully due to a bent or kinked.This lead was never in service, and a new lead was placed.No adverse patient effects were reported.
 
Manufacturer Narrative
The product has been received for analysis.Upon completion of the failure analysis of the complaint product, if there is any further relevant information from that review, a supplemental report will be filed.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 and 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.
 
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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 Key18096960
MDR Text Key328503136
Report Number2124215-2023-62930
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 12/26/2023
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 Number197897
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/30/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/24/2023
Initial Date FDA Received11/08/2023
Supplement Dates Manufacturer Received12/04/2023
Supplement Dates FDA Received12/26/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/02/2023
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 Age60 YR
Patient SexMale
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