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 Premature Discharge of Battery (1057)

Patient Problems Dyspnea (1816); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/30/2021

Event Type  Injury  

Event Description

It was reported that an asymptomatic patient's pacemaker exhibited premature battery depletion when it reached an early elective replacement indicator on (b)(6) 2021.Notification was discovered in clinic by a healthcare provider on (b)(6) 2021.Patient noted some shortness of breath and mild edema, unknown if related to the device.Device was explanted and replaced on (b)(6) 2021.Patient was stable after the procedure.

Manufacturer Narrative

Analysis was normal.No anomalies were found.

• 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
• MDR Report Key: 11952236
• MDR Text Key: 254824515
• Report Number: 2017865-2021-21039
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734509091
• UDI-Public: 05414734509091
• Combination Product (y/n): N
• PMA/PMN Number: P030035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: PM3262
• Device Catalogue Number: PM3262
• Device Lot Number: A000030519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Congenital Anomaly
• Patient Weight: 53