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

Model Number PM3562

Device Problems Failure to Interrogate (1332); Interrogation Problem (4017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/19/2023

Event Type  malfunction  

Manufacturer Narrative

Further information was requested but not received.

Event Description

It was reported that the pacer exhibited radio frequency (rf) telemetry anomaly.No intervention was performed.

Manufacturer Narrative

Correction: the b5 statement should have been "it was reported that the patient presented for a follow-up in the clinic.Upon interrogation, it was found that the pacer was failing to be interrogated via radio frequency (rf) telemetry.Programming changes were made.The patient was in the stable condition.", rather than "it was reported that the pacer exhibited radio frequency (rf) telemetry anomaly.No intervention was performed." the correct medical device code should have been "failure to interrogate", rather than "interrogation problem".The correct health effect impact code should have been "unexpected medical intervention", rather than "no health consequences or impact".The correct data in field e2, e3, and e4 should have been "yes, physician, and no information", rather than "no, non-hcp, no".

Event Description

It was reported that the patient presented for a follow-up in the clinic.Upon interrogation, it was found that the pacer was failing to be interrogated via radio frequency (rf) telemetry.Programming changes were made.The patient was in the stable condition.

• Brand Name: QUADRA ALLURE MP CRT-P
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 17892763
• MDR Text Key: 326121525
• Report Number: 2017865-2023-48048
• 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: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PM3562
• Device Lot Number: A000146717
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2023
• 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: QUARTET LEAD.; TENDRIL LEAD.; TENDRIL LEAD.
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 91 KG