MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ASSURA MP ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3369-40Q

Device Problems Failure to Deliver Shock/Stimulation (1133); Over-Sensing (1438); Incorrect Interpretation of Signal (1543); Under-Sensing (1661)

Patient Problems Death (1802); Ventricular Fibrillation (2130)

Event Date 06/15/2020

Event Type  Death  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported that the patient had passed away.Review of transcripts from (b)(6) 2020 had revealed that there was a ventricular fibrillation (vf) episode and the implantable cardioverter defibrillator delivered an unsuccessful shock.The vf episode then became very fine and the device was unable to sense the low amplitude fibrillation.The device eventually diagnosed "return to sinus" and stopped delivering therapy.Transcripts also revealed over-sensing episodes, but clinician suspects the episode is showing pulseless electrical activity.An agonal rhythm on far-field channel suggest that the patient had already passed away at the time of the episode.

Manufacturer Narrative

Correction:(b)(4).

Manufacturer Narrative

Correction: h6 should have included 1661 under-sensing in original report.

• Brand Name: QUADRA ASSURA MP ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10221194
• MDR Text Key: 197219937
• Report Number: 2017865-2020-08597
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508377
• UDI-Public: 05414734508377
• Combination Product (y/n): N
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: CD3369-40Q
• Device Catalogue Number: CD3369-40Q
• Device Lot Number: A000079748
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 86 YR