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 Problem Unspecified Infection (1930)

Event Date 12/03/2017

Event Type  Injury  

Event Description

It was reported that the patient presented in-clinic with tissue inflammation around the pacemaker pocket on (b)(6) 2017.The cause of the inflammation was a pocket infection.The patient was asymptomatic except for the inflammation.The pacemaker and leads were explanted.The patient was given an external pacing system; the patient was stable post procedure.

Event Description

New information received notes that patient was hospitalized with site infection at (b)(6) hospital.Patient was treated with iv antibiotics and transferred to vanderbilt university medical center for explant of device and leads.Patient was stable post procedure.

Manufacturer Narrative

Analysis was normal.No anomalies were found.

Manufacturer Narrative

The awareness date should have been 12/07/2017 rather than 12/08/2017.

• 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: 7117674
• MDR Text Key: 94852372
• Report Number: 2017865-2017-36043
• Device Sequence Number: 1
• Product Code: NKE
• 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,Followup,Followup,Followup
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: PM3262
• Device Lot Number: A000042445
• Other Device ID Number: 05414734509091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2017
• 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: 1458QL/86, (B)(4); 1888TC/58, (B)(4); 1999/52, (B)(4)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR