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

Model Number 1458Q/75

Device Problems Signal Artifact/Noise (1036); Low impedance (2285)

Patient Problems Syncope (1610); No Known Impact Or Consequence To Patient (2692)

Event Date 04/29/2019

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

Manufacturer report number: 2938836-2019-03733, manufacturer report number: 2938836-2019-03734.It was reported patient presented in the emergency room when noise on both the right atrial and right ventricular leads were noted.It was observed patient had received more than forty inappropriate therapies due to lead noise.The device was programmed doo and tachycardia therapies were disabled.The following day, the device was interrogated again, and the same noise was observed.Low pacing impedance was also noted on the right atrial, right ventricular and left ventricular leads.A chest x-ray was taken, and physician suspected lead abrasion was likely the cause of the noise and impedance drop.On (b)(6) 2019 just prior to procedure, the device was interrogated and low out of range high voltage (hv) lead impedance was observed.The right ventricular lead was explanted and replaced.The atrial lead was left in place and plugged in as the patient was chronic atrial fibrillation and device was programmed to vvi.During the procedure, pacemaker system analyzer testing on the left ventricular lead showed normal impedance and pacing characteristics and the lead remained implanted.There were no complications and patient was stable throughout.

Event Description

Related manufacturer reference number: 2938836-2019-13294 new information received notes, on arrival to the emergency, once in the room patient had potential episode of vt/vf, syncope and was reportedly pulselessness.He received chest compression and external shock to obtain return of pulses.Noise was also noted on the left ventricular lead.Prior to the procedure, the physician was concerned that the patient¿s device was not working correctly given the amount of interference and noise from the leads.The device was also explanted and replaced.

• 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 ; 8184932577
• MDR Report Key: 8610315
• MDR Text Key: 145112595
• Report Number: 2938836-2019-03735
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 05414734503334
• UDI-Public: 05414734503334
• 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,Followup
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Model Number: 1458Q/75
• Device Lot Number: 4086833
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2013
• 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 Age: 81 YR