SORIN OVATIO ICD VR-IMPLANTED 350053/6250 6250

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-17 for SORIN OVATIO ICD VR-IMPLANTED 350053/6250 6250 manufactured by Sorin Crm Sas.

Event Text Entries

[184254736] 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).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5093814
• MDR Report Key: 9848022
• Date Received: 2020-03-17
• Date of Report: 2020-03-15
• Date of Event: 2020-03-13
• Date Added to Maude: 2020-03-18
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SORIN OVATIO ICD VR-IMPLANTED
• Generic Name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• Product Code: MRM
• Date Received: 2020-03-17
• Model Number: 350053/6250
• Catalog Number: 6250
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SORIN CRM SAS

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Life Threatening; 3. Other; 4. Required No Informationntervention; 5. Deathisabilit	2020-03-17