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

Model Number 1458Q/86

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

Patient Problems Dizziness (2194); Palpitations (2467)

Event Date 08/20/2020

Event Type  Injury  

Manufacturer Narrative

This product is registered as a combination product.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that the patient experienced lightheadedness and palpitations and presented in the emergency room.Upon interrogation, it was noted that the right ventricular (rv) lead exhibited loss of capture and the left ventricular (lv) lead exhibited high capture threshold.A chest x-ray revealed that the rv lead was dislodged and the lv lead had been pulled back.The leads were explanted.A new rv lead was placed and the right vein was too occluded to place a lv lead.The patient was in stable condition.

Manufacturer Narrative

Code - 213 - no device problem found is the correct code not 3221 - no findings available.

Manufacturer Narrative

Analysis found that a complete lead was returned in one piece measuring 86.3 cm.Analysis was normal.No anomalies were found.

• 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
• MDR Report Key: 10505316
• MDR Text Key: 206083188
• Report Number: 2017865-2020-13258
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• Combination Product (y/n): N
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: 1458Q/86
• Device Catalogue Number: 1458Q-86
• Device Lot Number: A000052556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR; DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Weight: 91