MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD QUADRA ASSURA MP CRT-D, DF-4 CONNECTOR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3371-40QC

Device Problems Difficult to Interrogate (1331); Over-Sensing (1438)

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

Event Date 04/01/2014

Event Type  malfunction  

Event Description

It was reported that throughout the case, interrogation was difficult using radio frequency telemetry and inductive telemetry.Post successful dft testing noise was seen on all channels that led to device charging.During this time interrogation was not possible.The issue eventually resolved, and inductive and wireless communication could be reinitiated.Patient was asymptomatic and stable.

Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received.

• Brand Name: QUADRA ASSURA MP CRT-D, DF-4 CONNECTOR
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC., CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC., CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: cary lawler ; 645 almanor avenue; sunnyvale, CA 94085 ; 8184932621
• MDR Report Key: 3854585
• MDR Text Key: 4616974
• Report Number: 2938836-2014-11515
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

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: 12/31/2015
• Device Model Number: CD3371-40QC
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2014
• Initial Date FDA Received: 06/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2013
• 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: 62 YR