MAUDE Adverse Event Report: BOSTON SCIENTIFIC; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Device Problems Defibrillation/Stimulation Problem (1573); Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Hematoma (1884); Myocardial Infarction (1969)

Event Date 09/28/2012

Event Type  Injury  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.Friedman, d.J., c.S.Parzynski, et al.(2018)."ventricular fibrillation conversion testing after implantation of a subcutaneous implantable cardioverter defibrillator: a report from the national cardiovascular data registry." circulation: epub before print.(b)(6).

Event Description

Boston scientific received information from a journal article titled " ventricular fibrillation conversion testing after implantation of a subcutaneous implantable cardioverter defibrillator: a report from the national cardiovascular data registry".Data from the national cardiovascular database registry of first time s-icd recipients between september 28, 2012 and april 1, 2016 was studied to determine predictors of use of conversion testing (ct), predictors of an insufficient safety margin (ism) which was defined as vf conversion energy greater than 65 joules during testing and in-house outcomes associated with use of ct.Ct testing was performed in 5,624 patients (70.7 percent) of 7,960 s-icd patients.Of the patient's who underwent vf conversion testing, 336 had insufficient safety margins (unsuccessful conversion at less than or equal to 65 joules), although all had successful vf conversion at less than or equal to 80 joules.Two of the patients with insufficient safety margins required separate procedures to revise the s-icd.Adverse noted in the study include death, cardiac arrest, valve injury, hematoma (requiring intervention), hemothorax, infection, lead dislodgement, myocardial infarction, tia or stroke and urgent cardia surgery.There were no instances of cardiac perforation, pericardial tamponade, set screw problem or pneumothorax.There were no reported allegations that the implant procedure, the use of the product or product malfunction caused or contributed to the reported adverse events.

• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC
• Manufacturer Contact: timothy degroot ; 4100 hamline ave. n; st. paul, MN 55112 ; 6515826168
• MDR Report Key: 7704469
• MDR Text Key: 114502876
• Report Number: 2124215-2018-13263
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2018
• 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
• Event Location: Other
• Date Manufacturer Received: 07/11/2018
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention