MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM MRI S-ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number A219

Device Problem Interrogation Problem (4017)

Patient Problems Syncope (1610); Ventricular Tachycardia (2132); Heart Failure (2206)

Event Date 05/02/2019

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.

Event Description

It was reported that this patient experienced a syncopal event.It was noted that the patient does have a history of ventricular tachycardia (vt) and also has a left ventricular assist device (lvad).The caller stated the device did not have the capability to be interrogated.A boston scientific technical services could not determine from the caller if the device could not be interrogated or if they meant that they did not have the right programmer to perform device interrogation.The consultant discussed when and how this device stores episodes and that there are histograms or overall counters.It was reported that they had a report that showed smart pass had been enabled in the past and the device was able to be checked.Efforts to obtain additional complaint details were unsuccessful.No additional adverse patient effects were reported.

Event Description

This supplemental report is being filed to update the investigation conclusion code and additional manufacturing narrative.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited telemetry difficulty issues with no conclusive evidence of a malfunction; please refer to the description for more information regarding the specific circumstances of this event.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

• Brand Name: EMBLEM MRI S-ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8818827
• MDR Text Key: 151955853
• Report Number: 2124215-2019-14244
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526584404
• UDI-Public: 00802526584404
• Combination Product (y/n): N
• PMA/PMN Number: P110042/S058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/07/2019
• Device Model Number: A219
• Device Catalogue Number: A219
• Device Lot Number: 215675
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/24/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Required Intervention
• Patient Age: 44 YR