MAUDE Adverse Event Report: BOSTON SCIENTIFIC LEAD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number 184

Device Problems Impedance Problem (2950); Protective Measures Problem (3015); High Capture Threshold (3266)

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

Event Date 04/24/2023

Event Type  malfunction  

Event Description

D: caller provided patient name + dob.Caller reports device toning at 6 hours intervals.Reports that sounds like a beep then pause, then another beep.Rep reports that it sounds similar to an ekg machine.Patient recorded beeping and rep reports that they are not consistent w/ any mdt tone.Caller reported that tone has been going on since december.Asked for review.Caller also indicated that patient had high svc lead impedance alert, but tones were programmed off for that.R: reviewed most recent transmission from may 16 2023 and noted that last device tones were associated w/ svc impedance alert.No tones since april 26.Confirmed that tones are not associated w/ device.Observations (5).Svc lead impedance warning on (b)(6) 2023.High rv threshold on (b)(6) 2023.Patient activity less than 1 hr/day for 2 weeks.Vf detection may be delayed: vf detection interval is faster than 300 ms (200 bpm).Vt detection off but some vt therapies on.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: LEAD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 17488214
• MDR Text Key: 320696952
• Report Number: MW5120919
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/02/2023

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?: No
• Device Model Number: 184
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2023
• Patient Sequence Number: 1