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

Model Number A209

Device Problems High impedance (1291); Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Convert Rhythm (1540); Device Displays Incorrect Message (2591)

Patient Problems Death (1802); Ventricular Fibrillation (2130)

Event Date 12/15/2019

Event Type  Death  

Manufacturer Narrative

Following receipt of additional information, this event will be further updated.

Event Description

It was reported that the patient with this device presented with a ventricular fibrillation (vf) rhythm which was successfully detected by the implanted subcutaneous system.The device reportedly delivered five shocks; however all were ineffective at rate conversion.It was additionally noted that shock impedances were high out of range during four out of the five, shocking attempts.The initial data review noted 6 treated episodes with a total of 12 delivered shocks; all shocks ineffective at rate conversion and undersensing observed.The vf duration was noted as approximately 19 minutes from the beginning of detection to the final delivered shock.The data is to be uploaded for a technical services evaluation.The patient ultimately passed away.The field representative stated more data would be collected in absence of a returned product.At this time it is suspected that a device malfunction could have contributed to the patient's death.

Event Description

It was reported that the patient with this device presented with a ventricular fibrillation (vf) rhythm which was successfully detected by the implanted subcutaneous system.The device reportedly delivered five shocks; however all were ineffective at rate conversion.It was additionally noted that shock impedances were high out of range during four out of the five, shocking attempts.The initial data review noted 6 treated episodes with a total of 12 delivered shocks; all shocks ineffective at rate conversion and undersensing observed.The vf duration was noted as approximately 19 minutes from the beginning of detection to the final delivered shock.The data is to be uploaded for a technical services evaluation.The patient ultimately passed away.The field representative stated more data would be collected in absence of a returned product.At this time it is suspected that a device malfunction could have contributed to the patient's death.

Manufacturer Narrative

An engineering level technical review of the device data confirmed that the patients arrhythmia was appropriately detected by the s-icd electrode system and shock therapy was delivered accordingly; however, multiple shock attempts did not convert the arrhythmia.Based on the available data, the s-icd operated per programmed parameters and device design; there was no evidence of a product performance-related issue with the devices function.Detailed review by boston scientific clinicians and engineers of the device diagnostic data, as well the x-rays depicting the challenges associated with the implant location of this sicd electrode system, leads to the observation that defibrillation therapy was likely rendered ineffective by the implant position of the s-icd electrode and the presence of adipose tissue beneath the electrode coil.

• Brand Name: EMBLEM 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: 9552489
• MDR Text Key: 173748171
• Report Number: 2124215-2019-27640
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526544101
• UDI-Public: 00802526544101
• Combination Product (y/n): N
• PMA/PMN Number: P110042/S043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/05/2020

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: 03/10/2018
• Device Model Number: A209
• Device Catalogue Number: A209
• Device Lot Number: 113995
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/19/2019
• Initial Date FDA Received: 01/06/2020
• Supplement Dates Manufacturer Received: 01/20/2020
• Supplement Dates FDA Received: 02/05/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Death