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

Model Number PM3262

Device Problems Failure to Interrogate (1332); Pacemaker Found in Back-Up Mode (1440); Telemetry Discrepancy (1629)

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

Event Date 04/02/2019

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 during an initial implant procedure, the device was found to be in backup vvi.During the procedure, the pulse generator exhibited difficulty getting rf telemetry.An auditory alert went off while preparing to hand the device to the physician.It was attempted to interrogate the device by placing a wand cover; however, the programmer displayed that the device was in backup vvi.Due to the patient being on the table with an open pocket and the time it would take to recover the device, the device was not used and was replaced.The patient was stable throughout the event.

Manufacturer Narrative

The reported event of backup mode was confirmed.The device was received in backup mode and its voltage was at beginning-of-life level.After recovering the device to its normal operating mode, electrical and mechanical tests indicated normal device functionality.Despite extensive efforts the backup condition could not be reproduced.There were no anomalies found that could help determine the cause of backup operation occurred in the field.As a result of this finding, abbott is performing further investigation.

• Brand Name: QUADRA ALLURE MP RF CRT-P
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8520137
• MDR Text Key: 142124353
• Report Number: 2938836-2019-02814
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 05414734509091
• UDI-Public: 05414734509091
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910023
• 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,Followup
• Report Date: 06/24/2019

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: PM3262
• Device Lot Number: A000075996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/02/2019
• Initial Date FDA Received: 04/16/2019
• Supplement Dates Manufacturer Received: 06/10/2019
• Supplement Dates FDA Received: 06/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2019
• 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 Weight: 100