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

Model Number PM3242

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

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

Event Date 11/05/2019

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

Related manufacturer reference number: 2938836-2019-16293.It was reported that the patient presented for an implant procedure.It was noted that the patient experienced diaphragmatic jump because of the left ventricular lead.The pacemaker was noted to be in backup.The lead and device were not used and replaced.The patient was stable.

Manufacturer Narrative

The device was received in backup mode which was discovered during the implant procedure and review of the device image indicates it was caused by power on reset condition.After re-loading the product code successfully, the device was tested under electrical and mechanical conditions and results indicated normal functionality and battery voltage at near beginning-of-life level.Further evaluation including monitoring the device for several days under load did not find any anomaly.Despite extensive efforts to trigger backup condition, it could not be reproduced.As a result of this finding, abbott is performing further investigation.

• Brand Name: ALLURE QUADRA 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
• MDR Report Key: 9324676
• MDR Text Key: 166545998
• Report Number: 2938836-2019-16289
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734507912
• UDI-Public: 05414734507912
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 04/14/2020

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: 09/30/2020
• Device Model Number: PM3242
• Device Catalogue Number: PM3242
• Device Lot Number: P000077408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/05/2019
• Initial Date FDA Received: 11/14/2019
• Supplement Dates Manufacturer Received: 04/13/2020
• Supplement Dates FDA Received: 04/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2019
• 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: 67 YR
• Patient Weight: 70