Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RELIANCE 4-FRONT; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION RELIANCE 4-FRONT; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) Back to Search Results
Model Number 0672
Device Problems Mechanical Problem (1384); Failure to Read Input Signal (1581); Positioning Problem (3009); High Capture Threshold (3266)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/31/2023
Event Type  malfunction  
Event Description
It was reported that this right ventricular (rv) defibrillation lead exhibited a poor current of injury, low r-wave amplitude measurements and poor thresholds during implant.After three attempts to reposition the lead, the helix would no longer retract.The lead was then removed from the body and the helix was noted to no longer retract or extend and torque was building on the lead with no transfer to the helix.Another rv lead was successfully implanted and the procedure was completed.This lead was attempted, but not implanted.No adverse patient effects were reported.The return of the product is expected.At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.
 
Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, visual inspection of the lead found that the helix mechanism was extended and dried blood was noted in the helix housing.After removing the dried body fluid, the helix mechanism was fully functional.Based upon the clinical observations and the laboratory findings, we believe that body fluid inside the helix housing may have contributed to the irregularity in helix function.
 
Event Description
It was reported that this right ventricular (rv) defibrillation lead exhibited a poor current of injury, low r-wave amplitude measurements and poor thresholds during implant.After three attempts to reposition the lead, the helix would no longer retract.The lead was then removed from the body and the helix was noted to no longer retract or extend and torque was building on the lead with no transfer to the helix.Another rv lead was successfully implanted and the procedure was completed.This lead was attempted, but not implanted.No adverse patient effects were reported.The return of the product is expected.At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.The product has been received for analysis.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
RELIANCE 4-FRONT
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
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 Key16761923
MDR Text Key313505422
Report Number2124215-2023-18224
Device Sequence Number1
Product Code LWS
Combination Product (y/n)Y
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/17/2023
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 Lay User/Patient
Device Model Number0672
Device Catalogue Number0672
Device Lot Number206978
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/31/2023
Initial Date FDA Received04/18/2023
Supplement Dates Manufacturer Received07/10/2023
Supplement Dates FDA Received07/17/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/11/2023
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 Age72 YR
Patient SexFemale
-
-