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

Model Number CD3369-40C

Device Problems Failure to Capture (1081); Telemetry Discrepancy (1629)

Patient Problems Dizziness (2194); Loss Of Pulse (2562)

Event Date 10/10/2017

Event Type  Injury  

Event Description

It was reported that a pacer dependent patient presented in-clinic for follow-up.While running a threshold test, the "cancel test" was greyed out longer than expected.Loss of capture was noted on the implantable cardioverter defibrillator.For a few beats, the patient was asystolic and became very lightheaded.The programmer was later reengaged and pacing resumed.Telemetry discrepancy with the merlin programmer was suspected.The patient was stable and would continue to be monitored.

• 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: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7015135
• MDR Text Key: 91527159
• Report Number: 2017865-2017-34361
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/09/2017

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: 08/31/2018
• Device Model Number: CD3369-40C
• Device Catalogue Number: CD3369-40C
• Device Lot Number: A000027757
• Other Device ID Number: 05414734508346
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2017
• Initial Date FDA Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2016
• 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
• Treatment: 3650,30572
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR