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 Device Operates Differently Than Expected (2913)

Patient Problems Arrhythmia (1721); Dyspnea (1816); Palpitations (2467)

Event Date 09/03/2017

Event Type  malfunction  

Event Description

It was reported that the patient experienced palpitations and shortness of breath when lying on the left side.The patient had multiple episodes of the cardiac resynchronization therapy pacemaker initiating extra beats due to inappropriate firing.It induced atrial or ventricular arrhythmias.The patient was admitted in the hospital on (b)(6).The device was reevaluated, interrogated, and reprogrammed.The patient was discharged on (b)(6).The patient was stable and would continue be followed up routinely.

• 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: 6975061
• MDR Text Key: 90754151
• Report Number: 2017865-2017-33591
• 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
• Report Date: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 82 YR