MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM A219 SICD W/CELLULAR BASE STATION; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number A219

Device Problems Failure to Deliver Shock/Stimulation (1133); Failure to Sense (1559); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Ventricular Fibrillation (2130)

Event Date 07/23/2021

Event Type  malfunction  

Event Description

Date: (b)(6) 2021; patient: (b)(6); physician: (b)(6), procedure: subcutaneous icd generator replacement and testing moderate sedation (34 minutes); indication: icd at eri, procedural details: the patient was brought to the electrophysiology lab in a stable fasting condition.The chest was prepped and draped in the usual fashion.Preprocedural antibiotics were administered.Forty cc's of 1% lidocaine were infiltrated subcutaneously and an incisions were made in laterally through the prior scar.The sicd was explanted and a new device was inserted.The pocket was flushed and closed.Vf was induced, detection was prolonged due to under sensing and 65 j shock failed to terminate vf.He was defibrillated externally.Moderate sedation with 115 mg propofol iv, 2 mg versed iv and fentanyl 100 mcg iv.Start time 1354.End time 1428.We will repeat dft's in the near future and if we are unable to reliably defibrillate, change to an icd.This is a boston scientific device they implanted, replacing a cameron with emblem a219 on (b)(6) 2021, the a219 failed to sense vf, and i was wondering how do i find out if device is on recall.They left the cameron lead in and connected it to a219 cellular model base station.Fda safety report id# (b)(4).

• Brand Name: EMBLEM A219 SICD W/CELLULAR BASE STATION
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 12406412
• MDR Text Key: 269588887
• Report Number: MW5103637
• Device Sequence Number: 1
• Product Code: LWS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A219
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/31/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 77