MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET LEAD SMALL-S, 86 CM; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number 1456Q/86

Device Problems Device Dislodged or Dislocated (2923); Material Twisted/Bent (2981); High Capture Threshold (3266)

Patient Problems Dyspnea (1816); No Known Impact Or Consequence To Patient (2692)

Event Date 11/05/2018

Event Type  malfunction  

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 presented in clinic with increased thresholds.A chest x-ray was performed and it was noted that the left ventricular lead experienced possible micro-dislodgement.It was also noted that there was possible kinking of the lead.No further information is available.

Event Description

New information received on dec 10, 2018, indicates that the patient presented in the emergency department with shortness of breath.A chest x-ray was performed which noted possible kinking on the left ventricular lead and no dislodgement was noted.It was also noted that the patient had ventricular tachycardia that was below the detection limit.Programming changes were made and the patient was stable.

• Brand Name: QUARTET LEAD SMALL-S, 86 CM
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• 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: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8111016
• MDR Text Key: 128613273
• Report Number: 2017865-2018-17900
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734510158
• UDI-Public: 05414734510158
• 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,Followup
• Report Date: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: 1456Q/86
• Device Catalogue Number: 1456Q/86
• Device Lot Number: S000048834
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2017
• 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): Hospitalization
• Patient Age: 75 YR
• Patient Weight: 55