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

Model Number A219

Device Problems High impedance (1291); Failure to Sense (1559); Connection Problem (2900)

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

Event Date 06/24/2020

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 system exhibited out of range shock impedance measurements and no sensing is all vectors.X rays were obtained which confirmed that the electrode's terminal pin was completely removed from the subcutaneous implantable cardioverter defibrillator (s-icd) header.The electrode position looked to be maintained.A revision procedure will occur next week.A boston scientific technical services consultant documented and discussed the clinical observations with the caller.No adverse patient effects were reported.

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.The 3191 code was utilized due to the surgery that occurred.

Event Description

It was reported that a revision procedure was subsequently performed and this device was removed from service and replaced.The associated electrode remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

The returned device was thoroughly inspected and analyzed.The setscrew was confirmed to operate normally.Inspection noted that because the electrode had separated from the header port while implanted, bodily fluid contamination was present inside the port.A laboratory test lead was able to be inserted into the port and properly secured.The device was successfully interrogated and a memory download was performed.The device was then exposed to simulated heart load conditions, and the defibrillation and sensing functions were tested.The device operated appropriately, according to its performance specifications with no out of range measurements or interruptions in therapy output.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.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

This supplemental report is being filed due to the completed evaluation of this product.

• 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: 10255601
• MDR Text Key: 198329708
• Report Number: 2124215-2020-13673
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/25/2021

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: 03/25/2021
• Device Model Number: A219
• Device Catalogue Number: A219
• Device Lot Number: 244541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Initial Date Manufacturer Received: 06/24/2020
• Initial Date FDA Received: 07/09/2020
• Supplement Dates Manufacturer Received: 07/16/2020; 02/01/2021
• Supplement Dates FDA Received: 10/08/2020; 02/25/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 66 YR