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

Model Number CD3369-40Q

Device Problems Incorrect Interpretation of Signal (1543); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 06/25/2020

Event Type  Injury  

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 received inappropriate anti tachycardia pacing therapy for an episode of atrial fibrillation with rapid ventricular response.Upon examination of the episode, it appeared that the timing programmed caused the atrial rhythms to fall into a blanking period.This caused the device to diagnose a higher ventricular rhythm ratio than the atrial rhythm and subsequently delivering the inappropriate therapy.Programming changes were recommended.The clinic did not report any patient symptoms.

Manufacturer Narrative

Additional information: a4 and b5.

Event Description

New information received stated that on (b)(6), 2020 the patient was seen in clinic and the recommended programming changes were completed.No patient symptoms were noted at this visit.The patient presented again for a follow up in (b)(6) of 2020 and there were no further incidents of inappropriate shock.

• 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: 10286665
• MDR Text Key: 199218232
• Report Number: 2017865-2020-09370
• 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
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: CD3369-40Q
• Device Catalogue Number: CD3369-40Q
• Device Lot Number: A000043926
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/26/2020
• Initial Date FDA Received: 07/16/2020
• Supplement Dates Manufacturer Received: 12/16/2020
• Supplement Dates FDA Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 117