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

Model Number A219

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Failure to Read Input Signal (1581); Battery Problem (2885); Device Sensing Problem (2917); Impedance Problem (2950)

Patient Problems Injury (2348); Electric Shock (2554); No Known Impact Or Consequence To Patient (2692); No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/17/2020

Event Type  Injury  

Manufacturer Narrative

Efforts to obtain additional complaint details were unsuccessful.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 following implant of this subcutaneous implanted cardioverter defibrillator, this patient was shocked twenty five times.Shock impedance measurements were within normal limits but varied from 70 ohms to 172 ohms.The device was in primary vector and a wandering baseline, rail-to-rail noise, flat lines and intermittent non-physiologic blips were all observed in various stored episodes.A boston scientific technical services consultant discussed further troubleshooting and device evaluation should be performed.No adverse patient effects were reported.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Investigation of the available information determined this device exhibited oversensing due to noise, with no conclusive evidence of a specific cause.Please see the description for more information regarding the specific circumstances of this event.The 3191 code was utilized due to the surgery that occurred.

Event Description

It was reported that electrode positioning looked appropriate at implant; however, the electrode migrated with the patient tissue during body movement and the device could not detect cardiac electricity.The device was programmed off and a revision procedure was performed.The physician used the three incision technique to lock the electrode in place.The patient experienced trauma due to the additional surgery.No additional adverse patient effects were reported.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Investigation of the available information determined this device exhibited oversensing due to noise, with no conclusive evidence of a specific cause.Please see the description for more information regarding the specific circumstances of this event.The 3191 code was utilized due to the surgery that occurred.

Event Description

This report is being filed due to updated coding.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Investigation of the available information determined this device exhibited oversensing due to noise, with no conclusive evidence of a specific cause.Please see the description for more information regarding the specific circumstances of this event.

Event Description

It was reported that this caller expressed concern regarding a decrease in remaining longevity of this device.A boston scientific technical services consultant reviewed the device data and suspects the previously reported defibrillation therapy caused the observed decrease in longevity.The device is exhibiting normal battery depletion.No adverse patient effects were reported.

• 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: 11207067
• MDR Text Key: 227923625
• Report Number: 2124215-2021-01050
• 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: company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/10/2022
• Device Model Number: A219
• Device Catalogue Number: A219
• Device Lot Number: 133731
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/21/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 55 YR