MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ALLURE MP RF CRT-P; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM3262

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bruise/Contusion (1754); Chest Pain (1776); Unspecified Infection (1930); Swelling (2091)

Event Date 06/19/2018

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported that during an office visit on (b)(6) 2018, the patient complained of chest pain and discomfort, racing/skipping heart beats, swelling of hands and feet, cough, cold and heat intolerance, indigestion bruising easily, ringing of the ear difficult swallowing.The right atrial lead exhibited decreased atrial sensing and high capture threshold.The lead was confirmed to be dislodged under fluoroscopy and chest x-ray.The lead was repositioned on (b)(6) 2018.The pacemaker pocket was also revised to a more medial position.During the pocket revision, a yellowish serosanguineous fluid was noted in the pocket and a wound culture was sent out to the laboratory for analysis.The pocket was irrigated with antibiotic solution and the pacemaker was reused.Patient was stable.

• Brand Name: QUADRA ALLURE MP RF CRT-P
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• 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: 7769565
• MDR Text Key: 116643625
• Report Number: 2017865-2018-11554
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 05414734509091
• UDI-Public: 05414734509091
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910023
• 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: 08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: PM3262
• Device Lot Number: A000045018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2017
• 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
• Treatment: 2088TC, (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 83