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

Model Number 1458Q/86

Device Problems Failure to Capture (1081); High Capture Threshold (3266)

Patient Problems Dyspnea (1816); Edema (1820)

Event Date 11/30/2017

Event Type  Injury  

Event Description

It was reported that few weeks after device implant, patient was admitted to hospital with congestive heart failure exacerbation.The patient was experiencing weight gain, increasing dyspnea on exertion and ble edema.The left ventricular capture threshold was high.It was noted that the lv lead was placed at inferior posterolateral positon due to patient¿s anatomy.There was left ventricular pacing but it was not enough to compensate.At higher output, the patient would feel simulations at some sites.The lv lead was explanted and an epicardial lead was implanted.The patient condition after the procedure was good.

Event Description

New information received notes that loss of capture was also noted.

Manufacturer Narrative

Analysis was normal.No anomalies were found.

• Brand Name: QUARTET
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7158134
• MDR Text Key: 96175477
• Report Number: 2938836-2018-00027
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: 1458Q/86
• Device Lot Number: A000042981
• Other Device ID Number: 05414734503198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2017
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 85 YR