MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCIVA ICD VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	D400
Medical Device Problem Codes	High impedance (1291); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Electric Shock (2554); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) recorded a code 1005, indicative of shocking into an open circuit.This device also recorded high out of range shocking impedance values.Technical services (ts) recommended further review and possible replacement of the associated right ventricular (rv) lead.Information from the field suggested that the physician discussed system replacement with the patient, however they chose to leave the emergency room (er) against medical advice.This device remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) recorded a code 1005, indicative of shocking into an open circuit.This device also recorded high out of range shocking impedance values.Technical services (ts) recommended further review and possible replacement of the associated right ventricular (rv) lead.Information from the field suggested that the physician discussed system replacement with the patient, however they chose to leave the emergency room (er) against medical advice.This device remains in service.No adverse patient effects were reported.It was subsequently reported that this device delivered appropriate therapy and that the impedance on the therapy was high and out of range.It was further reported that commanded shocks had been performed and that the impedance results were lower than with the delivered therapy.Technical services (ts) could not establish a reason for the in-range shock impedances, as no apparent changes had been made to the device programming.Continued monitoring by the physician was planned.

• Brand Name: PERCIVA ICD VR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• 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: 17850805
• Report Number: 2124215-2023-53939
• Device Sequence Number: 3389936
• Product Code: LWS
• UDI-Device Identifier: 00802526587863
• UDI-Public: 00802526587863
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2023

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/04/2024
• Device Model Number: D400
• Device Catalogue Number: D400
• Device Lot Number: 114406
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/11/2023
• Supplement Date Received by Manufacturer: 11/10/2023
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 11/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2022
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male