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

Model Number PM3542

Device Problem Loose or Intermittent Connection (1371)

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

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 implant procedure on an unknown date the pacemaker set screw would not tighten.The physician elected to use a different device to complete the procedure.The patient condition was stable.

Manufacturer Narrative

Analysis was normal.No anomalies were found.

Event Description

New information indicates that the event was noted during an unrelated procedure in (b0(6) 2021.

• Brand Name: QUADRA ALLURE MP
• 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: 11600527
• MDR Text Key: 243326335
• Report Number: 2017865-2021-13439
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 05414734510080
• UDI-Public: 05414734510080
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/03/2021

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: 06/30/2021
• Device Model Number: PM3542
• Device Catalogue Number: PM3542
• Device Lot Number: P000094461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/18/2021
• Initial Date FDA Received: 03/31/2021
• Supplement Dates Manufacturer Received: 06/24/2021; 10/11/2021; 10/20/2021
• Supplement Dates FDA Received: 06/24/2021; 10/15/2021; 11/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1