MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET LEAD SMALL-S, 86 CM; PERMANENT PACEMAKER ELECTRODE

Model Number 1456Q/86

Device Problem Use of Device Problem (1670)

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

Event Date 11/30/2022

Event Type  malfunction  

Event Description

It was reported that the patient presented to the hospital for a left ventricular (lv) lead implant procedure on (b)(6) 2022.While attempting to implant the lead, it was noted that after multiple implant attempts, the lead flushed abnormally.The anomalous lead was removed and replaced without further incident in the same procedure.The patient condition is unknown.

Manufacturer Narrative

Further information was requested, but not received.

Manufacturer Narrative

The reported events were unable to implant and ¿lead flushed abnormally¿.As received, a complete lead was returned in one piece.The reported event of ¿lead flushed abnormally¿ was not confirmed.Flush test of the lead did not find any anomalies.Electrical testing did not find any indication of conductor fractures or internal shorts.Visual inspection of the lead did not find any anomalies except for procedural damage.

Event Description

New information received notes while attempting to implant the left ventricular lead, it was noted that the lead flushed abnormally and a higher than normal level of force was used on the flushing syringe but the lead would not emit the flush on the distal end the patient was in stable condition.

• Brand Name: QUARTET LEAD SMALL-S, 86 CM
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 16275053
• MDR Text Key: 308524471
• Report Number: 2017865-2023-04643
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734510158
• UDI-Public: 05414734510158
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/20/2023

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 Model Number: 1456Q/86
• Device Catalogue Number: 1456Q/86
• Device Lot Number: A000123086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/11/2023
• Initial Date FDA Received: 01/31/2023
• Supplement Dates Manufacturer Received: 02/09/2023; 03/14/2023
• Supplement Dates FDA Received: 03/01/2023; 03/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2022
• 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
• Treatment: DURATA.; GALLANT.; TENDRIL.
• Patient Age: 78 YR
• Patient Sex: Female