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

Model Number PM3242

Device Problems Premature Discharge of Battery (1057); Incorrect Measurement (1383)

Patient Problem Stroke/CVA (1770)

Event Date 08/11/2021

Event Type  Injury  

Event Description

It was reported that the pacemaker dependent patient presented to the emergency room for suspected transient ischemic attack.An interrogation was performed, and it was discovered that the pacemaker had reached eri.The last clinic check was done january 2020 and the battery longevity was 3-4 years.The device was explanted and replaced.The patient was in stable condition.

Manufacturer Narrative

Analysis was normal.No anomalies were found.

Event Description

It was reported that the pacemaker dependent patient presented to the emergency room for suspected transient ischemic attack.An interrogation was performed, and it was discovered that the pacemaker had reached eri.The last clinic check was done january 2020 and the battery longevity was 3-4 years.The device exhibited overestimation.The device was explanted and replaced.The patient was in stable condition.

• Brand Name: ALLURE QUADRA 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 12388283
• MDR Text Key: 268817240
• Report Number: 2017865-2021-29343
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734507912
• UDI-Public: 05414734507912
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P030035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2015
• Device Model Number: PM3242
• Device Catalogue Number: PM3242
• Device Lot Number: 4414017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2014
• 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): Required Intervention