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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 Mechanical Problem (1384); Under-Sensing (1661); Device Dislodged or Dislocated (2923); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/14/2023
Event Type  Injury  
Event Description
It was reported that this right ventricular (rv) lead exhibited undersensing measurements on the presenting electrogram (egm) of intrinsic beats, and the rv automatic capture (rvac) feature was not successful for two months.An xray was performed and showed the rv lead was dislodged from the original position.Subsequently, a revision procedure was performed.The physician attempted to extend and retract the helix, but the helix could not be retracted completely, and it was decided to explant the rv lead.There was noticeable tissue on the helix.Additionally, it was noted that the generator suture tie had also detached.This was observed after the physician opened up the pocket for the lead revision and it was concluded that the loose generator had ratcheted the lead overtime, causing it to dislodge.The original generator was reimplanted and tied down with two suture ties and two extra suture sleeves were also placed and tied down to the new lead.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.A laboratory technician tested the helix mechanism and found it was nonfunctional, confirming the clinical observation.Based upon the clinical observations and the laboratory findings, we believe that body fluid and/or tissue inside the helix housing may have contributed to the irregularity in helix function.Then testing was completed to assess lead electrical performance, inner and outer insulation integrity.Measurements throughout these tests were within normal limits.Microscopic inspections of the terminal pin assembly, and lead body found no anomalies.Laboratory testing was unable to reproduce the reported clinical observations and detailed analysis did not reveal any abnormalities regarding the undersensing and dislodgment observations.
 
Event Description
It was reported that this right ventricular (rv) lead exhibited undersensing measurements on the presenting electrogram (egm) of intrinsic beats, and the rv automatic capture (rvac) feature was not successful for two months.An xray was performed and showed the rv lead was dislodged from the original position.Subsequently, a revision procedure was performed.The physician attempted to extend and retract the helix, but the helix could not be retracted completely, and it was decided to explant the rv lead.There was noticeable tissue on the helix.Additionally, it was noted that the generator suture tie had also detached.This was observed after the physician opened up the pocket for the lead revision and it was concluded that the loose generator had ratcheted the lead overtime, causing it to dislodge.The original generator was reimplanted and tied down with two suture ties and two extra suture sleeves were also placed and tied down to the new lead.No additional adverse patient effects were reported.
 
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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 degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key16396551
MDR Text Key309752939
Report Number2124215-2023-07326
Device Sequence Number1
Product Code LWS
UDI-Device Identifier00802526592829
UDI-Public00802526592829
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number0672
Device Catalogue Number0672
Device Lot Number189665
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/14/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/17/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/06/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
Patient Age46 YR
Patient SexFemale
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