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

Model Number 1458Q-86

Device Problems Device Dislodged or Dislocated (2923); High Capture Threshold (3266)

Patient Problems Twiddlers Syndrome (2114); Palpitations (2467)

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 there was a case of ratchet syndrome and the patient's left ventricular lead moved gradually and was found to be bent into an eight shape in the pocket through x-ray.Twelve weeks later, the threshold increased.Three weeks after that, the patient presented to the hospital due to palpitations caused by ectopic pacing.Five weeks later, the device was removed and an epicardial lead was placed.Prior to the surgery, x-shaped torsion was noted via x-ray.There was a possibility that the entire lead had been pulled along with elimination of the twist.The patient was stable.

• Brand Name: QUARTET LEAD
• 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
• MDR Report Key: 9438177
• MDR Text Key: 169855685
• Report Number: 2017865-2019-17604
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 12/09/2019

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 Model Number: 1458Q-86
• Device Catalogue Number: 1458Q-86
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/20/2019
• Initial Date FDA Received: 12/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR