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

Model Number 1058T/86

Device Problem Signal Artifact/Noise (1036)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/30/2018

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 patient in the emergency room received inappropriate shocks during interrogation when the wand was placed over the device, the noise was interpreted as ventricular fibrillation by the device.Before, during and after the shocks, the patient had a stable, though not regular, placed rhythm on the er monitor.Uninterpretable noise was also noted on the right ventricular, right atrial and left ventricular leads.When leads were tested through psa, there was no noise noted on any leads.The baseline noise noted on an earlier merlin.Net transmission was only for the competitor right ventricular lead.Shock therapy was turned off and device stopped pacing altogether.Quickly, the therapy was turned back on, pacing resumed and patient received more inappropriate shock.Once the wand was off, no more shocks and irregular pacing was noted.Device malfunction was suspected.A magnet was placed over the device, pacing normalized and patient did not receive any more shocks.Patient was transferred to a different hospital for device replacement.Upon arrival at the hospital, the magnet had been removed and patient was having symptomatic pauses in pacing and received additional inappropriate shocks.The patient arrested requiring cpr and a temporarily pacer to stabilize for procedure.The device and the competitor right ventricular lead were explanted and replaced.Right atrial and left ventricular leads remain implanted and connected to the new device.Patient was discharged and in good health.

• Brand Name: QUICKSITE XL LV
• 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: 8167939
• MDR Text Key: 130467705
• Report Number: 2938836-2018-12996
• Device Sequence Number: 1
• Product Code: OJX
• 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: 12/16/2018

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: 03/31/2011
• Device Model Number: 1058T/86
• Device Lot Number: 0002127103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2018
• Initial Date FDA Received: 12/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2008
• 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: MODEL: 1688TC/58, SERIAL: (B)(4); MODEL: 6947-65, SERIAL: (B)(4); MODEL: CD3357-40C, SERIAL: (B)(4)
• Patient Age: 77 YR