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 RESONATE EL ICD VR; 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 RESONATE EL ICD VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) Back to Search Results
Model Number D432
Device Problem Failure to Sense (1559)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/28/2022
Event Type  malfunction  
Event Description
It was reported that this implantable cardioverter defibrillator (icd) was implanted and connected to the leads, however, it exhibited failure to sense intrinsic beats.Subsequently, the device was explanted and the previous non-boston scientific device was re-connected as it was showing appropriate sensing.No additional adverse patient effects were reported.The device is not expected to be returned as it was discarded.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
RESONATE EL ICD VR
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
cashel road
clonmel
EI  
Manufacturer Contact
timothy degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key15864777
MDR Text Key305532318
Report Number2124215-2022-49087
Device Sequence Number1
Product Code LWS
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P960040/S385
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
Report Date 11/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberD432
Device Catalogue NumberD432
Device Lot Number300220
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/25/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
-
-