MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCIVA ICD DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	D401
Medical Device Problem Codes	High impedance (1291); Battery Problem (2885); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd), implanted with another manufacturer's right ventricular (rv) defibrillation lead, exhibited a high out-of-range shock impedance measurement greater than 200 ohms.Shock impedance measurements fluctuated between 80 and >200 ohms with changes in posture and positioning.Rv lead fracture was suspected, and lead revision was scheduled.Prior to the procedure, the physician discussed the keeping the current icd vs.Replacing the icd during the same procedure.The icd was had been implanted for 5 months at the time of the lead revision, but a battery longevity estimate showed approximately 4 years remaining.Technical services (ts) explained that long telemetry sessions over the past week to evaluate the rv lead appear to have impacted battery longevity estimates.During the lead revision, additional lead and device evaluation in the pocket further supported that the variable and high out-of-range shock impedance measurements were likely attributed to compromised rv lead integrity.The rv lead was surgically abandoned and replaced.Additional information received approximately a year later reported that this implantable cardioverter defibrillator (icd), implanted with another manufacturer's right ventricular (rv) defibrillation lead last october, was emitting beep tones and the patient's parents were concerned about his heart rate.It was noted that the patient was on medication and currently travelling with family on vacation without a remote monitor.Ts discussed the history of out-of-range shock impedance measurements from (b)(6) 2023, and review of recent shock impedance trends revealed intermittently high out-of-range shock impedance measurements greater than 125 ohms on this newer rv lead.Troubleshooting options and programming considerations were reviewed, and the patient was scheduled for an office visit after the family returned from vacation.This implantable cardioverter defibrillator (icd) system remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.

• Brand Name: PERCIVA ICD DR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 20020838
• Report Number: 2124215-2024-51905
• Device Sequence Number: 8600936
• Product Code: LWS
• UDI-Device Identifier: 00802526587894
• UDI-Public: 00802526587894
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/20/2024

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/05/2025
• Device Model Number: D401
• Device Catalogue Number: D401
• Device Lot Number: 256222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 08/21/2024
• Date Device Manufactured: 04/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 24 MO
• Patient Sex: Male