MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET LEAD DOUBLE BEND, 75 CM; PERMANENT PACEMAKER ELECTRODE

Model Number 1457Q/75

Device Problems Break (1069); Loose or Intermittent Connection (1371)

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

Event Date 03/14/2022

Event Type  malfunction  

Event Description

Related manufacturer reference number: 2017865-2022-07075, related manufacturer reference number: 2017865-2022-07076.It was reported that the patient presented in clinic for follow up.Device interrogation revealed dislodgement on the left ventricular (lv) lead and atrial lead.The physician elected to explant and replace the lv and atrial lead.The replacement lv lead was found to have a loose connector pin and was unable to be implanted.A new lv lead was successfully implanted.The patient condition was stable.

Manufacturer Narrative

The reported events were ¿loose connector pin¿ and lead dislodgement.As received, a complete lead was returned in one piece.The reported event of ¿loose connector pin¿ was not confirmed.Visual examination of the lead did not find any anomalies.Electrical testing did not find any indication of conductor fractures or internal shorts.Double-bend height was measured to be within specification.

• Brand Name: QUARTET LEAD DOUBLE BEND, 75 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: 14005549
• MDR Text Key: 288602371
• Report Number: 2017865-2022-07077
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 05414734510172
• UDI-Public: 05414734510172
• 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
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 1457Q/75
• Device Catalogue Number: 1457Q/75
• Device Lot Number: A000102016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2020
• 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 RIGHT VENTRICULAR LEAD; QUADRA ASSURA ICD
• Patient Age: 78 YR
• Patient Sex: Female