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

Model Number PM3242

Device Problems Failure to Interrogate (1332); Pacemaker Found in Back-Up Mode (1440); Wireless Communication Problem (3283)

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

Event Date 06/29/2020

Event Type  malfunction  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported that the patient presented in clinic for a routine evaluation.Upon interrogation, the pacemaker was in a slow telemetry mode.The settings of the device were as they were previously.The physician elected to proceed with the slow evaluation, which was caused by the delay in downloading diagnostic data.Near the end of the interrogation, there was a momentary loss of telemetry, then the device reported the backup vvi error.A data dump occurred as a result of the bvvi reset.The physician suspected the device was resetting and ended the session.The physician reprogrammed the device to the prior settings after the bvvi reset message.The patient was stable.

• Brand Name: ALLURE QUADRA RF 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: 10247190
• MDR Text Key: 198009124
• Report Number: 2017865-2020-08871
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734507912
• UDI-Public: 05414734507912
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/08/2020

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: 08/31/2020
• Device Model Number: PM3242
• Device Catalogue Number: PM3242
• Device Lot Number: A000075756
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/29/2020
• Initial Date FDA Received: 07/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2019
• 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 Age: 78 YR