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

Model Number A219

Device Problems Device Difficult to Program or Calibrate (1496); Inaccurate Synchronization (1609); Unintended Electrical Shock (4018)

Patient Problem Atrial Flutter (1730)

Event Date 12/19/2019

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 delivery of a 10 joule shock from this subcutaneous implantable cardioverter defibrillator (s-icd) during implant testing put the patient into atrial flutter.Difficulty was then encountered with completing the automatic setup process and a signal amplitude too high message was observed.The automatic setup was attempted again and completed successfully.No additional adverse patient effects were reported.This product remains implanted and in service.

Event Description

It was reported that delivery of a 10 joule shock from this subcutaneous implantable cardioverter defibrillator (s-icd) during implant testing put the patient into atrial flutter.Difficulty was then encountered with completing the automatic setup process and a signal amplitude too high message was observed.The automatic setup was attempted again and completed successfully.No additional adverse patient effects were reported.This product remains implanted and in service.

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's delivery of a shock may have contributed to unintentional induction of or acceleration of an arrhythmia.Please see the description for more information regarding the specific circumstances of this event.

• 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: 9592287
• MDR Text Key: 175082397
• Report Number: 2124215-2020-00698
• 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
• Report Date: 04/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/30/2021
• Device Model Number: A219
• Device Catalogue Number: A219
• Device Lot Number: 255700
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/19/2019
• Initial Date FDA Received: 01/15/2020
• Supplement Dates Manufacturer Received: 02/13/2020
• Supplement Dates FDA Received: 04/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 34 YR