MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD UNIFY ASSURA DR CRT-D; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3361-40

Device Problem Difficult to Interrogate (1331)

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

Event Date 11/25/2014

Event Type  malfunction  

Event Description

It was reported that during the initial interrogation of the device at implant, telemetry was lost.The programming parameters were sent to the icd, however, due to the interruption in telemetry, the information was not reported back to the programmer.It was unclear if therapy was enabled.The programmer was switched off, and a successful interrogation was completed and all original parameters were restored.There were no adverse consequences to the patient.

Manufacturer Narrative

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

• Brand Name: UNIFY ASSURA DR CRT-D
• 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: sharon mathew ; 645 almanor avenue; sunnyvale, CA 94085 ; 4085226327
• MDR Report Key: 4382332
• MDR Text Key: 5291876
• Report Number: 2938836-2015-00052
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• 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

• Date FDA Received: 01/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Model Number: CD3361-40
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2013
• 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