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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 High impedance (1291); Device Dislodged or Dislocated (2923); Positioning Problem (3009)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/28/2023
Event Type  malfunction  
Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the analysis of the complaint device, 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 attempted during implantation.The physician experienced placement difficulties and the lead dislodged after positioning the lead on the coronary sinus.On subsequent attempts the lead exhibited high out of range impedance with values of over 2300 ohms.This lead was removed and replaced with a new lead prior to pocket closure.No adverse patient effects were reported.The device is expected to be returned for analysis.
 
Event Description
It was reported that this right ventricular (rv) lead was attempted during implantation.The physician experienced placement difficulties and the lead dislodged after positioning the lead on the coronary sinus.On subsequent attempts the lead exhibited high out of range impedance with values of over 2300 ohms.This lead was removed and replaced with a new lead prior to pocket closure.No adverse patient effects were reported.The device is expected to be returned for analysis.The device was returned for analysis.
 
Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the analysis of the complaint device, 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 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.Visual inspection found body fluid in the helix housing.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 of dislodgement, difficult to position and high out of range pacing.
 
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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 Key16732194
MDR Text Key313213125
Report Number2124215-2023-17384
Device Sequence Number1
Product Code LWS
Combination Product (y/n)N
Reporter Country CodeFR
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
Report Date 06/26/2023
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 Number0672
Device Catalogue Number0672
Device Lot Number204503
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/28/2023
Initial Date FDA Received04/13/2023
Supplement Dates Manufacturer Received06/21/2023
Supplement Dates FDA Received06/26/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/26/2022
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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