MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET LEAD DOUBLE BEND, 86 CM; PERMANENT PACEMAKER ELECTRODE

Model Number 1457Q/86

Device Problems High Capture Threshold (3266); Migration (4003)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 04/23/2019

Event Type  malfunction  

Manufacturer Narrative

The results of the investigation are unconfirmed 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: 2017865-2019-06526.It was reported that the patient initially had phrenic nerve stimulation which was reprogrammed (b)(6) 2019, resolved and the patient was stable.On (b)(6) 2019 an increase in capture thresholds was observed on the left ventricular lead.Programming changes were made but a device longevity diagnostic anomaly was noted.Further evaluation in clinic revealed battery longevity to be normal with improvement expected once right ventricular thresholds and backup heart rate were lowered.The patient has had no high ventricular rates and no shocks or therapies.There was a concern the patient had been doing much work with his upper extremities and the left ventricular lead may have adjusted slightly.This issue was brought up with the patient.The patient denied any other symptoms and was stable.

• Brand Name: QUARTET LEAD DOUBLE BEND, 86 CM
• 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: 8583422
• MDR Text Key: 144173180
• Report Number: 2017865-2019-06525
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 05414734510189
• UDI-Public: 05414734510189
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: 1457Q/86
• Device Lot Number: A000064518
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/23/2019
• Initial Date FDA Received: 05/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2018
• 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: QUADRA ASSURA MP ICD
• Patient Age: 78 YR