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

Model Number PM3562

Device Problem Pacemaker Found in Back-Up Mode (1440)

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

Event Date 04/05/2021

Event Type  malfunction  

Event Description

It was reported that the patient presented for a pacemaker implant.During the procedure prior to implant, the unopened pacemaker that was intended to be implanted was found in backup vvi mode upon interrogation.The device was not used.No patient was directly involved.

Manufacturer Narrative

Analysis has confirmed that environmental factors resulted in the event.

• 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
• MDR Report Key: 11726877
• MDR Text Key: 247478871
• Report Number: 2017865-2021-15943
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 05414734510097
• UDI-Public: 05414734510097
• Combination Product (y/n): N
• PMA/PMN Number: P030035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: PM3562
• Device Catalogue Number: PM3562
• Device Lot Number: P000112499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1