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 Failure to Sense (1559); Failure to Read Input Signal (1581)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/24/2021
Event Type  malfunction  
Event Description
It was reported that during the implant procedure after positioning this right ventricular (rv) lead, low amplitude was noted from the pacemaker system analyzer (psa).The physician attempted to exchange the psa and reposition the rv lead, but low amplitudes and sometimes loss of sensing were still noted.The physician exchanged the rv lead to resolve the event and no adverse patient effects were reported.The rv lead is expected for analysis, but has not yet been received.
 
Manufacturer Narrative
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/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.
 
Event Description
It was reported that during the implant procedure after positioning this right ventricular (rv) lead, low amplitude was noted from the pacemaker system analyzer (psa).The physician attempted to exchange the psa and reposition the rv lead, but low amplitudes and sometimes loss of sensing were still noted.The physician exchanged the rv lead to resolve the event and no adverse patient effects were reported.The rv lead was subsequently 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
MDR Report Key12113850
MDR Text Key260447633
Report Number2124215-2021-17664
Device Sequence Number1
Product Code LWS
Combination Product (y/n)Y
PMA/PMN Number
P910073/S145
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/21/2021
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 Expiration Date10/01/2021
Device Model Number0672
Device Catalogue Number0672
Device Lot Number115501
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/14/2021
Initial Date Manufacturer Received 05/24/2021
Initial Date FDA Received07/03/2021
Supplement Dates Manufacturer Received07/06/2021
Supplement Dates FDA Received09/21/2021
Patient Sequence Number1
-
-