MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VARIOUS ICDS; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Date 01/01/2011

Event Type  malfunction  

Event Description

Cicenia, marianna, et al.(2023)."icd outcome in pediatric arrhythmogenic cardiomyopathy." international journal of cardiology, https://doi.Org/10.1016/j.Ijcard.2023.131381 it was reported in the above journal article that in nineteen pediatric patients with arrhythmogenic cardiomyopathy (acm) that underwent implantation of an implantable cardioverter defibrillator (icd) between january 2011 and december 2022 (15 patients were implanted with a subcutaneous icd, or s-icd, and 4 patients were implanted with a transvenous icd, or tv-icd), appropriate therapies occurred in a minority of primary prevention patients and frequently in secondary prevention patients.The rate of inappropriate shock therapy and device-related complications were rare and most often wound related.For tv-icd systems specifically: one patient required lead repositioning due to lead dislodgement.In another patient, an inappropriate shock occurred during stress exceeding the ventricular tachycardia (vt) detection rate threshold.In this last case, the ventricular fibrillation (vf)/vt-detection rate threshold was increased, and beta-blocker therapy optimized.Please see the attached article for further details.

Manufacturer Narrative

If pertinent information is provided in the future, a supplemental report will be submitted.

• Brand Name: VARIOUS ICDS
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)
• 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 Key: 18471378
• MDR Text Key: 332985694
• Report Number: 2124215-2024-00702
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: No
• 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 Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1