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

Model Number CD3369-40Q

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Atrial Fibrillation (1729); Atrial Flutter (1730); Atrial Tachycardia (1731); Device Overstimulation of Tissue (1991); Shock from Patient Lead(s) (3162)

Event Date 05/12/2017

Event Type  Injury  

Event Description

It was reported that the patient experienced episodes of atrial tachycardia and atrial fibrillation with rapid ventricular rate, resulting in inappropriate shock therapies on (b)(6).On (b)(6), the patient was brought into the clinic and implantable cardioverter defibrillator was reprogrammed to resolve this issue.The patient was stable after the reprogramming.

Event Description

New information received.It was reported that the patient experienced episodes of atrial flutter.On (b)(6) 2017, the patient received a shock for ventricular fibrillation after the inappropriate anti-tachycardia pacing therapy.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6677222
• MDR Text Key: 78702344
• Report Number: 2017865-2017-05767
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study,use
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: CD3369-40Q
• Device Catalogue Number: CD3369-40Q
• Device Lot Number: A000029500
• Other Device ID Number: 05414734508377
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2017
• Initial Date FDA Received: 06/29/2017
• Supplement Dates Manufacturer Received: 07/13/2017
• Supplement Dates FDA Received: 07/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR