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 Failure to Disconnect (2541)

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

Event Date 10/14/2021

Event Type  malfunction  

Event Description

Related manufacturer reference number: 2017865-2021-36001, related manufacturer reference number: 2017865-2021-36002.It was reported that the patient presented to the clinic for a follow-up on (b)(6) 2021.During examination of leads, it was noted that the right ventricular (rv) lead had high capture threshold.Physician decided to explant the lead.While performing the explant procedure, right atrial (ra) lead was explanted as it was not needed anymore.Left ventricular (lv) was explanted along with other leads as it was adhered to rv lead.Physician placed a new rv lead and lv lead on (b)(6) 2021.After implanting the leads, physician felt that the newly implanted rv lead might have had abrasions due to extraction tools.The new rv lead was explanted and replaced with another lead in the same procedure.The patient was stable before, during and after the procedure.

Manufacturer Narrative

The lead was returned due to left ventricular lead explanted during procedure due to it being adhered to right ventricular lead.As received, only the distal portion of the lead was returned for analysis.Visual inspection of the lead found damage consistent with that occurring at time of procedure.All damage noted to lead was consistent with that occurring at time of procedure.

• 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: 12760347
• MDR Text Key: 280457658
• Report Number: 2017865-2021-36003
• 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
• Report Date: 02/18/2022

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 Expiration Date: 07/31/2022
• Device Model Number: 1456Q/86
• Device Catalogue Number: 1456Q/86
• Device Lot Number: A000084737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/14/2021
• Initial Date FDA Received: 11/07/2021
• Supplement Dates Manufacturer Received: 02/16/2022
• Supplement Dates FDA Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2019
• 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; DURATA
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 67 KG