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

Model Number 1458QL/86

Device Problems Failure to Capture (1081); Failure to Sense (1559); Device Dislodged or Dislocated (2923)

Patient Problems Twiddlers Syndrome (4563); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/07/2022

Event Type  Injury  

Event Description

Related manufacturer reference number: 2017865-2022-02064.Related manufacturer reference number: 2017865-2022-02065.It was reported that the patient had twiddler's syndrome after implant of their implantable cardioverter defibrillator was implanted.The left ventricular lead and atrial lead were not sensing nor capturing.Chest x-rays confirmed the leads had dislodged.The right ventricular lead was stable and in good position.The atrial lead and left ventricular lead were turned off.The implantable cardioverter defibrillator was programmed to right ventricular lead only.The patient was stable.

Manufacturer Narrative

Correction: h6 - clinical code updated to no clinical signs, symptoms or conditions, was previously reported as twiddlers syndrome.

Event Description

Additional information received notes that the implantable cardioverter defibrillator (icd) and leads were explanted.The patient condition was stable before, during, and after the procedure.

• 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: 13373653
• MDR Text Key: 284631943
• Report Number: 2017865-2022-02063
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734510219
• UDI-Public: 05414734510219
• Combination Product (y/n): Y
• Reporter Country Code: CA
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/02/2022

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 Expiration Date: 01/31/2024
• Device Model Number: 1458QL/86
• Device Catalogue Number: 1458QL/86
• Device Lot Number: A000106349
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/07/2022
• Initial Date FDA Received: 01/27/2022
• Supplement Dates Manufacturer Received: 09/20/2022; 10/31/2022
• Supplement Dates FDA Received: 09/20/2022; 11/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2021
• 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: QUADRA ASSURA MP ICD; TENDRIL STS
• Patient Outcome(s): Required Intervention