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

Model Number 1458QL/86

Device Problems Failure to Capture (1081); Device Sensing Problem (2917); Device Dislodged or Dislocated (2923); Migration (4003)

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

Event Date 06/27/2022

Event Type  Injury  

Event Description

It was reported that a chest x-ray indicated that both ra and lv leads were dislodged and pulled back.Physician suspected twiddler syndrome to be the cause.After interrogation, loss of capture on both leads were observed.Further information notes that the sensing numbers dropped dramatically on both leads.The leads will be revised in august.Patient was stable.Related manufacturer reference number: 2017865-2022-15310.

Event Description

New information notes that on 19 aug 2022, the leads were revised and replaced.Patient did not experience any adverse effects prior to, during or after the procedure.

Manufacturer Narrative

The reported event of lead dislodgement, failure to capture, and device sensing problem were not confirmed.As received, a complete lead was returned in one piece.Electrical testing and visual inspection did not find any anomalies.The s-curve height was measured to be within specification.

• 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
• 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: 15032716
• MDR Text Key: 304117214
• Report Number: 2017865-2022-15311
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734510219
• UDI-Public: 05414734510219
• 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: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1458QL/86
• Device Catalogue Number: 1458QL/86
• Device Lot Number: A000116948
• 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: 06/27/2022
• Initial Date FDA Received: 07/15/2022
• Supplement Dates Manufacturer Received: 08/19/2022; 09/14/2022
• Supplement Dates FDA Received: 08/30/2022; 09/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2021
• 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: DURATA MRI; GALLANT HF
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR
• Patient Sex: Female