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

Model Number 1458Q/86

Device Problems Failure to Capture (1081); Decreased Sensitivity (2534); Device Dislodged or Dislocated (2923)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 02/14/2020

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

Related manufacturer reference number: 2938836-2020-01704.It was reported that the patient presented in clinic shortly after implant with complaints of diaphragmatic stimulation from left ventricular (lv) lead, which was resolved with programming.The patient then came into clinic shortly after reprogramming for a follow up and it was discovered that sensing of r-waves had dropped and there was limited capture at high outputs on the lv lead, both of which were not issues at their previous visit.Once the patient was placed on the operating table an x-ray was taken of their leads and it was discovered that the right ventricular (rv) lead had tension due to no slack but was not dislodged and the lv lead had partially pulled back into the main body of the coronary sinus.The rv lead was unscrewed from its original position and re-screwed into a new location with acceptable new measurements.The lv lead was explanted and re-implanted into a different branch of the coronary sinus on (b)(6) 2020 and had successful capture at lower outputs.The patient was stable.

• Brand Name: QUARTET
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 9793672
• MDR Text Key: 182185287
• Report Number: 2938836-2020-01705
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 1458Q/86
• Device Catalogue Number: 1458Q-86
• Device Lot Number: A000081592
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2019
• 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: DURATA STS OPTIM ACTIVE FIXATION
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR