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

Model Number 1258T/86

Device Problem Intermittent Capture (1080)

Patient Problems Syncope (1610); Cardiac Arrest (1762)

Event Date 08/02/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a dependent patient presented into the emergency room with asystole and syncope.The patient had recent generator change out due to premature battery failure caused by high output programs.Loss of capture on the ventricular channel was noted.In clinic, all measurements were normal.A single episode of ventricular capture on the near field channel, with a flat-line on the far field channel was observed on a stored egm.An episode was detected as non-sustained rv oversensing.No noise was revealed with isometrics and pocket manipulations.Lv lead capture could not be obtained within the normal range.Chest x-ray to verify proper lead and pin connection to the header was performed.Recommended programming changes were made.The patient was discharged and will continue to be monitored via merlin.Net.No lead extraction will be performed.

• Brand Name: QUICKFLEX MICRO LV LEAD
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: jaime chavez ; 645 almanor avenue; sunnyvale, CA 94085 ; 8184934022
• MDR Report Key: 6028975
• MDR Text Key: 57397458
• Report Number: 2938836-2016-11192
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P030054
• 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: 08/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Model Number: 1258T/86
• Device Lot Number: 3839124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2016
• Initial Date FDA Received: 10/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2012
• 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
• Treatment: 7122Q/65/ (B)(4)
• Patient Outcome(s): Required Intervention