MAUDE Adverse Event Report: ABBOTT ALLURE RF; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM3222

Device Problems Wireless Communication Problem (3283); Interrogation Problem (4017)

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

Event Date 10/05/2021

Event Type  malfunction  

Event Description

During a follow-up in clinic, the device displayed intermittent telemetry.Technical support was contacted and confirmed that a telemetry lockout caused the telemetry anomaly.After several attempts, the device was successfully interrogated with no intervention.The patient was stable.

• Brand Name: ALLURE RF
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 12651865
• MDR Text Key: 277102446
• Report Number: 2017865-2021-34025
• Device Sequence Number: 1
• Product Code: NIK
• 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
• Report Date: 10/18/2021

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: 08/31/2022
• Device Model Number: PM3222
• Device Catalogue Number: PM3222
• Device Lot Number: P000117863
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/05/2021
• Initial Date FDA Received: 10/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2021
• 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