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

Model Number PM3562

Device Problems Failure to Interrogate (1332); Defective Device (2588)

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

Event Date 02/11/2021

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 device could not be interrogated using wireless telemetry.The device switched appropriately from an inductive to radio frequency (rf) communication, but rf communication could not be completed with any strength to complete interrogation.There was no patient involved.The device was not used.

Manufacturer Narrative

Customer complaint of radiofrequency (rf) communication anomaly was not confirmed.During analysis, a failure event was observed which was unrelated to the reported event.Final analysis found.¿device was received in backup mode.Device image analysis found the cause of backup to be u2 xena anomaly likely due to exposure to cold temperatures.Product code was downloaded, and analysis was performed.Backup operation was reproduced at cold temperature and this is consistent with xena ic anomaly.Assessment of total projected longevity was performed and device was in normal range of operation with appropriate longevity remaining.

Manufacturer Narrative

Correction: section 6 - investigation conclusions should have been " 4307 - cause traced to component failure" rather than " 4315 - cause not established".

• Brand Name: QUADRA ALLURE MP 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
• MDR Report Key: 11343955
• MDR Text Key: 232401173
• Report Number: 2017865-2021-09057
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 05414734510097
• UDI-Public: 05414734510097
• Combination Product (y/n): N
• PMA/PMN Number: P030035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2021

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: 05/31/2022
• Device Model Number: PM3562
• Device Catalogue Number: PM3562
• Device Lot Number: P000113191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/11/2021
• Initial Date FDA Received: 02/18/2021
• Supplement Dates Manufacturer Received: 03/19/2021; 04/05/2021
• Supplement Dates FDA Received: 04/04/2021; 04/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1