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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
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BOSTON SCIENTIFIC CORPORATION; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) Back to Search Results
Device Problems Defective Device (2588); Data Problem (3196)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/12/2024
Event Type  Injury  
Event Description
It was reported that a ventricular tachycardia (vt) episode was not stored on the implantable cardioverter defibrillator (icd).The patient was wearing a holter monitor, which detected the vt episode.Technical services (ts) reviewed the data with the physician and noted that the vt episode rate was 150 bpm.This vt episode did not meet the programmed duration criteria to be stored as a vt episode.The reason for the holter monitor remains unknown, and further information was requested from the field.This investigation will be updated when further information becomes available.This icd remains in-service.No adverse patient effects were reported.
 
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Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
Manufacturer Contact
timothy degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key18921849
MDR Text Key337875338
Report Number2124215-2024-16080
Device Sequence Number1
Product Code LWS
Combination Product (y/n)N
Reporter Country CodeGM
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 03/18/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/12/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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