MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION; IMPLANTABLE DEVICE

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Telemetry Discrepancy (1629)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2005

Event Type  malfunction  

Event Description

It was reported via a journal article that a study was performed to examine incidence, clinical impact, and management of left ventricular assist device (lvad) related electromagnetic interference (emi) on patients with a concomitant implantable cardioverter defibrillator (icd) device.The retrospective analysis study, covering a 16-year period, included a total of 737 patients from three healthcare facilities (hcfs).There were 264 patients with an icd device manufactured by boston scientific and 225 patients with a right ventricular (rv) lead manufactured by boston scientific.There was a total of 11 patients with a lvad and a boston scientific icd concomitant system that exhibited emi.Specific personal and device identification information of the study patients was not provided.Icd interrogation reports were reviewed to collect data on emi.Patients with emi were further evaluated to determine the clinical impact of emi on icd function and the intervention undertaken for it.Lvad-related emi noise resulted in oversensing, inappropriate mode switches, noise reversion, inhibition of pacing, inappropriate detection of atrial fibrillation (af) and inappropriate detection as ventricular tachycardia (vt) or ventricular fibrillation (vf).This noise interference persisted, resolved spontaneously, or resolved with a device programming change.A rv lead revision was required to resolve the noise in one patient.The manufacturer of the rv lead was not identified.In addition to emi noise, there was also lvad-related emi telemetry interference observed.The telemetry interference resulted in the inability to conduct icd interrogations, including threshold or sensing testing, as well as lead impedance measurements.The telemetry interference was resolved successfully with using a metal shield over the lvad and the icd, an encased wand, a radiofrequency tower, a different icd programmer or by increasing the distance between the icd programmer and lvad.Icd device replacement was required to reestablish successful communication in three patients, all identified as having icd devices manufactured by st.Jude medical.The study concluded that emi from lvad impacts icd function, although the incident rate is low.The majority of telemetry interference occurred with older generation devices and is no longer common with the new generation devices.Since a large portion of patients still have older generation lvad and icd implanted in them, physicians should be cognizant of conservative techniques that may help resolve telemetry interference.Unlike telemetry interference, lvad-related noise remains a problem in new generation lvads.In most cases, lvad-related noise resolves spontaneously or with icd device programming changes.

• Type of Device: IMPLANTABLE DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CLONMEL LIMITED; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 14317701
• MDR Text Key: 291229553
• Report Number: 2124215-2022-15492
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1