MAUDE Adverse Event Report: ST. JUDE MEDICAL PROMOTE; CARDIOVERTER DEFIBRILLATOR

Model Number 3207-06

Device Problems Defibrillation/Stimulation Problem (1573); Under-Sensing (1661)

Patient Problems Atrial Fibrillation (1729); Tachycardia (2095)

Event Date 07/28/2012

Event Type  Death  

Event Description

Failure to rescue the decay delay.Pt had an episode of double tachycardia (atrial fibrillation and ventricular fibrillation) with a ventricular rate of 270 bpm.The device undersensed the episode and misclassified a few beats as return to sinus rhythm and shock was not delivered.

• Brand Name: PROMOTE
• Type of Device: CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL; st. paul MN 55117
• MDR Report Key: 6124168
• MDR Text Key: 60870749
• Report Number: MW5066253
• Device Sequence Number: 1
• Product Code: MVK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3207-06
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: DURATA RV-LEAD: (MODEL 7120, SN #(B)(4)); QUICK PREY LV LEAD (MODEL 1156T, SN #(B)(4)); TRENDRIL A-LEAD (MODEL 1888TC, SN # (B)(4))
• Patient Outcome(s): Death
• Patient Age: 70 YR
• Patient Weight: 79