FDA Adverse Event Malfunction Summary report: N

LIFEVEST WCD 4000 SYSTEM

MDR report key: 21002190 · Received December 23, 2024

Report

Report Number: 3008642652-2024-12698
Event Type: Malfunction
Date Received: December 23, 2024
Date of Event: December 14, 2024
Report Date: December 23, 2024
Manufacturer: ZOLL MANUFACTURING CORPORATION
Product Code: MVK
PMA / PMN Number: P010030
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: PA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

BASED ON THE DATA AVAILABLE AT THIS TIME, THERE IS NO INDICATION OF A DEVICE MALFUNCTION CAUSING OR CONTRIBUTING TO THE INAPPROPRIATE TREATMENT. INAPPROPRIATE DEFIBRILLATIONS ARE AN ANTICIPATED RISK ASSOCIATED WITH THE USE OF THE LIFEVEST. PATIENTS ARE INSTRUCTED THROUGH ALARMS, VOICE MESSAGES, IFU, AND TRAINING TO PRESS THE RESPONSE BUTTONS TO PREVENT AN INAPPROPRIATE DEFIBRILLATION. THE CURRENT COMMERCIAL INAPPROPRIATE DEFIBRILLATION RATE IS CONSISTENT WITH THE OBSERVED RATE DURING THE PIVOTAL CLINICAL TRIAL G960083 (0.69% PER PATIENT-MONTH WITH 90% CONFIDENCE). A SUMMARY OF THE SAFETY AND EFFECTIVENESS DATA (SSED), INCLUDING THE INAPPROPRIATE DEFIBRILLATION SAFETY OBJECTIVE SUPPORTING FDA'S APPROVAL OF THE LIFEVEST, CAN BE FOUND AT HTTP://WWW.ACCESSDATA.FDA.GOV/CDRH_DOCS/PDF/P010030B.PDF. THE LIFEVEST DETECTION ALGORITHM COMPLIES WITH IEC 60601-2-4 PERFORMANCE REQUIREMENTS FOR SENSITIVITY AND SPECIFICITY.

Description of Event or Problem · 0

A PATIENT RECEIVED AN INAPPROPRIATE SHOCK. MOTION ARTIFACT CONTRIBUTED TO THE FALSE DETECTION. THE RESPONSE BUTTONS WERE PRESSED AFTER TREATMENT. THE PATIENT DID NOT SEEK MEDICAL ATTENTION. THE PATIENT CONTINUES WEARING LIFEVEST.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
88358	LIFEVEST WCD 4000 SYSTEM	WEARABLE CARDIOVERTER DEFIBRILLATOR	MVK	ZOLL MANUFACTURING CORPORATION	LIFEVEST WCD 4000 SYSTEM

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown