FDA Adverse Event Malfunction Summary report: N

EMBLEM S-ICD

MDR report key: 16758572 · Received April 17, 2023

Report

Report Number: 2124215-2023-18171
Event Type: Malfunction
Date Received: April 17, 2023
Date of Event: February 1, 2016
Report Date: April 17, 2023
Manufacturer: BOSTON SCIENTIFIC CORPORATION
Product Code: LWS
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

SHINGO SASAKI, YUJI ISHIDA, YUICHI TOYAMA, KIMITAKA NISHIZAKI, TAKAHIKO KINJO, SHOGO HAMAURA, TAIHEI ITOH, MASAOMI KIMURA, HIROFUMI TOMITA . (2022). "PROPENSITY SCORE-MATCHED COMPARISON OF CLINICAL OUTCOMES BETWEEN SUBCUTANEOUS IMPLANTABLE CARDIOVERTER- DEFIBRILLATOR WITH SMART PASS TECHNOLOGY AND TRANSVENOUS IMPLANTABLE CARDIOVERTER- DEFIBRILLATOR THERAPY." 87TH ANNUAL MEETING OF JAPAN CARDIOVASCULAR SOCIETY.

Description of Event or Problem · 0

IT WAS REPORTED VIA ABSTRACT FROM THE 87TH ANNUAL MEETING OF JAPAN CARDIOVASCULAR SOCIETY THAT THE AUTHORS STUDIED CONSECUTIVE 266 PATIENTS WHO UNDERWENT BOTH TRANSVENOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) IMPLANTATION BETWEEN FEBRUARY 2016 AND JULY 2022. DURING THE MEDIAN FOLLOW-UP PERIOD OF 1229 DAYS, THE INCIDENCE OF APPROPRIATE SHOCK THERAPY WAS 7.6% AND 6.7% IN S-ICD AND TRANSVENOUS ICD PATIENTS, RESPECTIVELY. INAPPROPRIATE SHOCKS WERE REPORTED AT 9.4% IN THE S-ICD GROUP AND 4.2% IN THE TRANSVENOUS ICD GROUP. INAPPROPRIATE SHOCKS IN THE S-ICD GROUP WERE CAUSED BY OVERSENSING DUE TO MULTIPLE FACTORS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1442573	EMBLEM S-ICD	IMPLANTABLE DEVICE	LWS	BOSTON SCIENTIFIC CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown