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

Model Number A209

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Fall (1848); Head Injury (1879)

Event Date 01/02/2023

Event Type  Injury  

Event Description

It was reported that the patient with this subcutaneous implantable cardioverter defibrillator (s-icd) experienced a fall on their head after receiving shock therapy.Although the therapy was appropriate, the health care professional (hcp) contacted technical services as a delay in therapy of about 10-15 seconds was suspected.Additional device data was requested by technical services in order to review the complete episode as well as device settings.Besides the fall, there were no other adverse patient effects reported.This s-icd remains in service.

Manufacturer Narrative

This device remains implanted; therefore, technical analysis cannot be conducted.Without a returned device it is not possible to definitively confirm how the device may have contributed to the complaint incident.If pertinent information is provided in the future, a supplemental report will be submitted.

Event Description

It was reported that the patient with this subcutaneous implantable cardioverter defibrillator (s-icd) experienced a fall on their head after receiving shock therapy.Although the therapy was appropriate, the health care professional (hcp) contacted technical services as a delay in therapy of about 10-15 seconds was suspected.Additional device data was requested by technical services in order to review the complete episode as well as device settings.Besides the fall, there were no other adverse patient effects reported.This s-icd remains in service.To date, no additional information has been received.Should additional follow-up information be provided in the future, an updated report will be issued.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16811909
• MDR Text Key: 313985341
• Report Number: 2124215-2023-19955
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526544101
• UDI-Public: 00802526544101
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P110042/S043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/20/2021
• Device Model Number: A209
• Device Catalogue Number: A209
• Device Lot Number: 256898
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other