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

Model Number PM3562

Device Problem Failure to Interrogate (1332)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2018

Event Type  malfunction  

Event Description

Before implantation and during the device preparation while in the packaging, the device could not be interrogated.A new device was used with no adverse consequences to the patient.

Manufacturer Narrative

The device could not be interrogated normally due to backup operation.Analysis of the device image revealed a power on reset (por) had occurred, which resulted in backup operation.There was also indication of code corruption and device id bit corruption.After downloading the product code, functional testing was performed and all test results were normal.The por condition could not be reproduced during the entire analysis and the root cause could not be determined.However, the reported event of telemetry anomaly was confirmed.

• Brand Name: QUADRA ALLURE MP CRT-P
• 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: 7698349
• MDR Text Key: 114315770
• Report Number: 2017865-2018-10512
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 05414734510097
• UDI-Public: 05414734510097
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: PM3562
• Device Catalogue Number: PM3562
• Device Lot Number: P000055415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2018
• 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