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

Model Number 1458QL/86

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Twiddlers Syndrome (2114)

Event Date 02/11/2019

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported that the patient experienced high voltage therapy and went to the hospital.Chest x-ray was performed indicating that both right atrial and right ventricular lead were dislodged.Upon device interrogation, the right ventricular lead exhibited oversensing leading to episodes of inappropriate anti-tachycardia pacing and high voltage therapy, decreased r-wave amplitude and both leads exhibited increased impedance.High voltage therapy was disabled, and the device was reprogrammed.The patient presented on (b)(6) 2019 for lead revision procedure.Upon opening the pocket, it was noted that the implantable cardioverter defibrillator was flipped, and the leads were twisted.It was suspected that the patient exhibited twiddle¿s syndrome.It was also noted that the left ventricular lead was also dislodged but exhibited good capture threshold.The right atrial and right ventricular lead were both explanted and replaced.The left ventricular lead and implantable cardioverter defibrillator were repositioned successfully and remain implanted.The patient was stable post 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: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8371469
• MDR Text Key: 137186405
• Report Number: 2017865-2019-02929
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734510219
• UDI-Public: 05414734510219
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/26/2019

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: 12/31/2020
• Device Model Number: 1458QL/86
• Device Catalogue Number: 1458QL/86
• Device Lot Number: A000051331
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/12/2019
• Initial Date FDA Received: 02/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2018
• 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: 1999/52, (B)(4); 7122Q/58, (B)(4); CD3371-40QC, (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR