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

Model Number CD3367-40QC

Device Problem Over-Sensing (1438)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/28/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that when an asymptomatic patient presented in clinic during follow-up, post-paced t-wave oversensing was observed on stored egm.Programming changes were made.Patient's condition was fine.

• Brand Name: QUADRA ASSURA ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (CRM-KISTA); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC. (CRM-KISTA); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: ulla strindlund ; box 7051; isafjordsgatan 15; kista SE-16-407 ; SW SE-16407 ; 4684744043
• MDR Report Key: 5321639
• MDR Text Key: 34747494
• Report Number: 3010215456-2015-32583
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: CD3367-40QC
• Device Lot Number: A000001460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2015
• 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