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

Device Problems Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Pain (1994); Discomfort (2330); Electric Shock (2554)

Event Date 06/01/2015

Event Type  Injury  

Event Description

Thienel, manuela, et al.(2022)."impairment of quality of life in patients with implanted subcutaneous cardioverter defibrillator (s-icd) compared to implanted transvenous cardioverter defibrillator therapy".Patient preference and adherence 2022:16 3027-3033.Https://doi.Org/10.2147/ppa.S378741.It was reported in a journal article review of 52 patients implanted with a subcutaneous implantable cardioverter defibrillator (s-icd) and 52 patients implanted with a transvenous implantable cardioverter defibrillator (tv-icd), 27.7% of s-icd patients expected their quality of life to improve by either deactivation or explantation of their device.Both s-icd and tv-icd groups reported inappropriate shock (ias) therapy, with a rate of 4.8 ias per patient year for the s-icd group.Patients reported pain, mental stress, and fear as a result of their shocks.Patient also reported discomfort and pain from the s-icd pocket itself.Of note, the study looked at patient implanted with 2nd- or 3rd-generation s-icd (boston scientific serial numbers a209 and a219).No additional information besides the journal article is available.

Manufacturer Narrative

No additional information is available.If additional information becomes available, the report will be updated at that time.

• 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
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17012218
• MDR Text Key: 316100680
• Report Number: 2124215-2023-26718
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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