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 DYNAMIC XT¿; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  • 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 DYNAMIC XT¿; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING Back to Search Results
Catalog Number M0042011010
Device Problems Material Deformation (2976); Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/13/2022
Event Type  malfunction  
Event Description
There is no prep for the device but it plugs into the cable, when it was plugged in the signals were not appropriate and the catheter looked bunched up on the mapping system, but it wasn't.The cable was unplugged and plugged back in.A new cable was tried also but didn't fix the problem.A new catheter was used and worked fine.Even though it was placed in the patient, the patient was not affected.The new device lot # (29452080).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DYNAMIC XT¿
Type of Device
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key15224230
MDR Text Key297878577
Report Number15224230
Device Sequence Number1
Product Code DRF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/05/2022,08/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberM0042011010
Device Lot Number29452080
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/29/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/05/2022
Event Location Hospital
Date Report to Manufacturer08/15/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-