MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET; PERMANENT PACEMAKER ELECTRODE

Model Number 1458Q/86

Device Problems Break (1069); Use of Device Problem (1670)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/30/2020

Event Type  malfunction  

Manufacturer Narrative

This product is registered as a combination product.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 patient presented for implant of the left ventricular lead.The lead was successfully placed in the coronary sinus and lead parameters were tested.The lead pulled back, into the sinus.An attempt to reinsert the lead was made, however the physician felt it was provided much more resistance than when initially placed.Insulation damage was suspected.A replacement lead was used to complete the procedure.The patient was stable.

Manufacturer Narrative

The reported event of insulation damage and resistance inserting in catheter were not confirmed.As received, a complete lead was returned in one piece.Visual inspection of the lead did not find any anomalies.Test found the lead was able to be inserted and removed in a catheter without difficulties.

• Brand Name: QUARTET
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 11182349
• MDR Text Key: 227556136
• Report Number: 2017865-2021-02257
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• Combination Product (y/n): N
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/18/2021

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: 04/30/2023
• Device Model Number: 1458Q/86
• Device Catalogue Number: 1458Q-86
• Device Lot Number: A000096629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/30/2020
• Initial Date FDA Received: 01/15/2021
• Supplement Dates Manufacturer Received: 02/12/2021
• Supplement Dates FDA Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1