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

Model Number 1456Q/86

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

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

Event Date 03/21/2022

Event Type  malfunction  

Event Description

It was reported that during an implant procedure, the stylet being used was found to be difficult to remove from the left ventricular (lv) lead.Malfunction was alleged on the lv lead.The lv lead was not implanted and a new lv lead was used to complete the procedure.The patient was stable throughout.

Manufacturer Narrative

Correction :h6: investigation conclusion code should be "unintended use error caused or contributed to event".

Manufacturer Narrative

The reported event of ¿the pin and inner lv coil pulled out of lead body¿ was confirmed.As received, a complete lead was returned in one piece with stylet stuck inside the lead.The ptfe coating of the stylet was found stripped and was bunched up / clogged up in the inner coil at the distal end of connector pin.The cause of the reported events was due to bunched up ptfe coating of the stylet that prevented the removal of the stylet and excessive forces resulted in the connector pin and cap to be pulled out of the connector assembly.A review of the device history record (dhr) confirmed that no issues were identified related to this reported event.

Manufacturer Narrative

Correction: b5- additional complaint of detached connector pin, which was not included in the initial report.Correction h6- additional code for detached connector pin, which was not included in the initial report.

Event Description

The connector pin on the left ventricular (lv) lead was also found to be detached.

• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 14053625
• MDR Text Key: 288886856
• Report Number: 2017865-2022-07477
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/28/2022

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: A000115473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2022
• Initial Date FDA Received: 04/08/2022
• Supplement Dates Manufacturer Received: 04/20/2022; 05/03/2022; 06/08/2022
• Supplement Dates FDA Received: 04/28/2022; 05/04/2022; 06/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2021
• 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: ASSURITY_PACEMAKER; DURATATACHY; TENDRIL STS
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 104 KG