MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION THE Q-TRAK SUBCUTANEOUS ELECTRODE; IMPLANTABLE LEAD

Model Number 3010

Device Problems Signal Artifact/Noise (1036); High impedance (1291); Device Sensing Problem (2917); Device Contamination with Chemical or Other Material (2944)

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

Event Date 11/18/2013

Event Type  Injury  

Event Description

It was reported that an alert was generated for this system due to a high shocking impedance measurement.A boston scientific technical services consultant reviewed the device data and identified the shocking impedance had been exhibiting a gradual increase since implant.There was a single atrial fibrillation (af) event with some noise, the consultant recommended troubleshooting and obtaining an x-ray to assess for anything grossly wrong with the electrode.A revision procedure was performed and poor sensing was noted in all vectors.Tissue encapsulation in the electrode end was suspected.The electrode was explanted and replaced.The associated subcutaneous implantable cardioverter defibrillator (s-icd) was also explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

This product is being evaluated in our post market quality assurance laboratory.This report will be updated when evaluation is complete.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, visual examination of the lead noted residue calcification on the shocking coil.Resistance and pressure tests were completed to assess electrical performance and inner insulation integrity.Measurements throughout these tests were within normal limits.Analysis determined that the impedance measurements may have been impacted by the calcification of body fluids on the shocking coil.Calcification, the process in which layers of calcium build up on a surface (e.G., leads), is a patient condition that develops over time in some populations.The mechanism of calcification is assumed to be associated with cell devitalization and accumulation of cellular debris following implantation.Past experience has shown that as calcified material builds up on the electrode surfaces of a lead, impedance measurements increase.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

It was reported that an alert was generated for this system due to a high shocking impedance measurement.A boston scientific technical services consultant reviewed the device data and identified the shocking impedance had been exhibiting a gradual increase since implant.There was a single atrial fibrillation (af) event with some noise, the consultant recommended troubleshooting and obtaining an x-ray to assess for anything grossly wrong with the electrode.A revision procedure was performed, and poor sensing was noted in all vectors.Tissue encapsulation in the electrode end was suspected.The electrode was explanted and replaced.The associated subcutaneous implantable cardioverter defibrillator (s-icd) was also explanted and replaced.No additional adverse patient effects were reported.

• Brand Name: THE Q-TRAK SUBCUTANEOUS ELECTRODE
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC; 4100 hamline avenue north; st. paul MN 55112
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 14709546
• MDR Text Key: 294126478
• Report Number: 2124215-2022-21597
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110042/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2015
• Device Model Number: 3010
• Device Catalogue Number: 3010
• Device Lot Number: A106272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2022
• Initial Date FDA Received: 06/15/2022
• Supplement Dates Manufacturer Received: 12/21/2022
• Supplement Dates FDA Received: 12/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male