MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) PROMOTE LAP; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3223-36P

Device Problem Telemetry Discrepancy (1629)

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

Event Date 04/18/2017

Event Type  malfunction  

Event Description

It was reported that when an asymptomatic patient presented in clinic for a device check.Upon an attempt to run a capture threshold test the device was unable to maintain telemetry and the device test was automatically cancelled.It was recommended to perform a manual threshold test.It was planned to do the test in (b)(6)when the patient returns to the clinic.Patient will continue to be monitored at regular intervals.

• Brand Name: PROMOTE LAP
• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6672045
• MDR Text Key: 78547524
• Report Number: 2017865-2017-04184
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2013
• Device Model Number: CD3223-36P
• Device Lot Number: 3490040
• Other Device ID Number: 05414734509336
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2011
• 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: 34 YR