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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM S-ICD ELECTRODE DELIVERY SYSTEM; IMPLANTABLE CATHETER
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BOSTON SCIENTIFIC CORPORATION EMBLEM S-ICD ELECTRODE DELIVERY SYSTEM; IMPLANTABLE CATHETER Back to Search Results
Model Number 4712
Device Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/31/2023
Event Type  Injury  
Event Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) catheter was found to have fractured during implant follow up.This catheter was subsequently explanted and replaced.No additional adverse patient effects were reported.
 
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Brand Name
EMBLEM S-ICD ELECTRODE DELIVERY SYSTEM
Type of Device
IMPLANTABLE CATHETER
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
780 brookside drive
spencer IN 47460
Manufacturer Contact
timothy degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key18386305
MDR Text Key331241734
Report Number2124215-2023-73059
Device Sequence Number1
Product Code LWS
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
P110042/S102
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 12/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date04/30/2022
Device Model Number4712
Device Catalogue Number4712
Device Lot Number25577069
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/07/2023
Initial Date FDA Received12/22/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/09/2020
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 Outcome(s) Required Intervention; Hospitalization;
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