MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ALLURE RF; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM3222

Device Problem Difficult to Interrogate (1331)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/22/2018

Event Type  malfunction  

Event Description

During an unrelated procedure, the time it took to interrogate the device increased significantly, and lead parameters were unable to be evaluated due to this extended interrogation time.The device was explanted and replaced.The patient was stable with no adverse consequences.

Manufacturer Narrative

Additional information: as received, the device was returned for analysis.The device was received in the normal range of operation.Analysis of the device image indicated average monthly voltage and current trends were normal.Telemetry tests were performed using rf communication to simulate field conditions by submerging the device in saline solution.Communication and reprogramming of the device over rf telemetry was successful.Temperature cycle and vibration testing were performed and indicated that device exhibited normal device characteristics.A battery assessment was performed and the battery voltage was still in the range of normal operation.Longevity assessment was performed and device was in the normal range of operation with appropriate remaining longevity.No device malfunction was revealed.

• Brand Name: ALLURE RF
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8004517
• MDR Text Key: 124975091
• Report Number: 2017865-2018-15898
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734507905
• UDI-Public: 05414734507905
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2015
• Device Model Number: PM3222
• Device Lot Number: 4644929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/23/2018
• Initial Date FDA Received: 10/25/2018
• Supplement Dates Manufacturer Received: 12/17/2018
• Supplement Dates FDA Received: 12/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2014
• 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