MAUDE Adverse Event Report: SORIN CRM SAS SORIN OVATIO ICD VR-IMPLANTED; DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Model Number 350053/6250

Device Problems Fracture (1260); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Chest Pain (1776); Dyspnea (1816); Dizziness (2194); Anxiety (2328); Electric Shock (2554)

Event Date 03/13/2020

Event Type  Injury  

Event Description

Pt experienced 5 shocks; a (b)(6) female with hocm with severe mr s/p implantable icd (vvi) for sustained vfib.Pt experienced the icd firing multiple shocks lasting 10 mins.At this time of event, she reported dizziness anxiety, shortness of breath and chest pain.No symptoms had been experienced of this icd since it was implanted in 2011.The last time the icd was interrogated was (b)(6) 2020.At the time, the pt was told that the battery life was at 3% and cannot be changed until it is completely dead as insurance will not pay for it.While at the hosp, she was taken for cardiac catheterization which showed no significant obstructive disease.Her icd was further interrogated by the mfr which revealed lead conductor fracture with battery status of elective replacement indicator.She was informed a new icd with new leads will be needed.A lifevest was ordered for the pt as a temporary solution until a decision is made by the family as they consult with primary physician, cardiologists and electrophysiologist on the appropriate treatment and steps for the pt.All indication of pt experience is the fractured of the icd lead which caused the malfunctioning of the device to shock the pt multiple times and causing her to be hospitalized.Fda safety report id# (b)(4).

• Brand Name: SORIN OVATIO ICD VR-IMPLANTED
• Type of Device: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• Manufacturer (Section D): SORIN CRM SAS
• MDR Report Key: 9848022
• MDR Text Key: 184254736
• Report Number: MW5093814
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 350053/6250
• Device Catalogue Number: 6250
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 75 YR
• Patient Weight: 66