MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) AESCULA LV LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number 1055K/75

Device Problems Failure to Capture (1081); Capturing Problem (2891)

Patient Problems Fatigue (1849); No Code Available (3191)

Event Date 11/30/2017

Event Type  malfunction  

Event Description

It was reported that the patient presented in clinic for follow-up.The patient complained of fatigue, bloating and heaviness in the legs.Upon interrrogation of the implantable cardioverter defibrillator, loss of capture was noted on the left ventricular channel.Capture threshold has been decreasing since (b)(6) 2017; lead was inappropriately detecting capture at the current programming.Programming changes were performed.

• Brand Name: AESCULA LV LEAD
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• 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: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7284609
• MDR Text Key: 100573614
• Report Number: 2017865-2018-02853
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2002
• Device Model Number: 1055K/75
• Device Lot Number: 0002391322
• Other Device ID Number: 05414734005029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2000
• 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: 47 YR