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

Model Number PM3562

Device Problem Intermittent Capture (1080)

Patient Problems Discomfort (2330); Syncope/Fainting (4411)

Event Date 05/31/2022

Event Type  Injury  

Event Description

Related manufacturer reference number: 2017865-2022-12805, related manufacturer reference number: 2017865-2022-12807.It was reported that a patient presented to the emergency room reporting falls and syncopal episodes.Upon examination, the patient¿s right ventricular (rv) and left ventricular (lv) lead were found to have intermittent loss of capture.The loss of capture was alleged on the patient¿s pacemaker.The rv and lv leads were found to also have high capture thresholds.Corrective programming changes were made.The patient was stable throughout.

Manufacturer Narrative

Further information was requested, but not received.

Manufacturer Narrative

Additional information: b3: event date is (b)(6) 2022.

Event Description

New information received notes that intermittent capture was alleged on the right ventricular (rv) and left ventricular (lv) leads.The event occurred on (b)(6) 2022.

• Brand Name: QUADRA ALLURE MP 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: 14738241
• MDR Text Key: 294871409
• Report Number: 2017865-2022-12804
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 05414734510097
• UDI-Public: 05414734510097
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: PM3562
• Device Catalogue Number: PM3562
• Device Lot Number: A000119375
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2021
• 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): Other
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 70 KG