ORCHESTRA

MDR report key: 1800151 · Received August 10, 2010

Report

Report Number: 9610579-2010-00572
Event Type: Malfunction
Date Received: August 10, 2010
Date of Event: July 22, 2010
Report Date: July 23, 2010
Manufacturer: SORIN CRM
Product Code: MRM
PMA / PMN Number: P980049
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: EI
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

Description of Event or Problem · 1

THE ORCHESTRA PROGRAMMER INVOLVED IN THIS MDR WAS USED TO INTERROGATE AN ICD (OVATIO DR) AFTER THE IMPLANT PROCEDURE. AL THE TESTS WERE PERFORMED (LEAD IMPEDANCE TESTS, RV/SVC CONTINUITY TEST, SENSING TESTS, PACING THRESHOLD TESTS). PT HAS SINUS NODE DYSFUNCTION SO HE WAS PACED CONTINUALLY. THE FOLLOWING EVENTS WERE OBSERVED DURING THE DIFFERENT VENTRICULAR FIBRILLATION INDUCTION PROCEDURES PERFORMED THAT DAY ((B)(6) 2010): OVERALL SLOW BEHAVIOR OF THE PROGRAMMER: SLOW OPERATION, SLOW ACCESS TO THE DIFFERENT SCREENS, SLOW PARAMETERS PROGRAMMING PROCESS, A VERY LONG TIME WAS NECESSARY TO REFRESH THE EPISODES. THE PROGRAMMER SCREEN FROZE COMPLETELY UPON FIRST T-WAVE VF INDUCTION: EVERYTHING WAS GREYED OUT AND ALL BUTTONS WERE INACTIVE; NO ECG WAS AVAILABLE. THE ICD OPERATED NORMALLY (SHOCK ON T-WAVE WAS DELIVERED) ALTHOUGH THE PROGRAMMER WAS STILL FROZEN. DIFFICULT TO SELECT AND PROGRAM DFT PARAMETERS. AT THE END OF THE DIFFERENT PROCEDURES (ALL WERE UNSUCCESSFUL TO INDUCE A VF), THE USER WAS UNABLE TO PROGRAM THE ICD BACK TO ITS PREVIOUS SETTINGS WITH THIS PROGRAMMER. ANOTHER PROGRAMMER WAS USED TO INTERROGATE THE ICD; HOWEVER, NO EPISODE DATED (B)(6) 2010 COULD BE RETRIEVED FROM THE IMPLANT MEMORY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ORCHESTRA		MRM	SORIN CRM	ORCHESTRA	0

Patients

Seq	Age	Sex	Outcome	Treatment
1