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

Model Number CD3371-40C

Device Problem Pacing Inadequately (1442)

Patient Problems Atrial Fibrillation (1729); Embolus (1830)

Event Date 04/20/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the patient presented to the hospital due to the atrial pace incorrectly causing atrial fibrillation.The patient was stuck in atrial arrhythmia and hemodynamically compromised before being hospitalized.The patient can not be cardioverted for now due to the presence of an observed blood clot in his raa.It is still unknown if the atrial fibrillation is device related.Disabling the atrial pace on pvc response is recommended.The patient was discharged while still in atrial fibrillation.No other changes were issued as the physician is waiting for the clot to dissolve.The patient will revisit for a follow-up in august.

Manufacturer Narrative

Correction: pma/510(k) # has been updated.

• Brand Name: QUADRA ASSURA MP ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: jaime chavez ; 645 almanor avenue; sunnyvale, CA 94085 ; 8184934022
• MDR Report Key: 5776080
• MDR Text Key: 48984257
• Report Number: 2938836-2016-05751
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/16/2018

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: 03/31/2017
• Device Model Number: CD3371-40C
• Device Lot Number: S000003343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/27/2016
• Initial Date FDA Received: 07/07/2016
• Supplement Dates Manufacturer Received: 09/28/2018
• Supplement Dates FDA Received: 10/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 67 YR