MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY ORCHESTRA; PROGRAMMER, PACEMAKER

Model Number ORCHESTRA PLUS

Device Problem Calibration Problem (2890)

Patient Problems Shock (2072); Ventricular Fibrillation (2130)

Event Date 02/27/2016

Event Type  Injury  

Event Description

On (b)(6) 2016, a patient was admitted to the hospital because of an arrhythmic storm of shocks (25) and the patient was sedated.When the user clicked on the eps screen to deliver an atp therapy, a calibration issue occurred with the interface of the subject programmer involved into the interrogation.Therefore, a ventricular fibrillation (vf) induction was clicked instead of the atp and an external shock should have been delivered to reduce the ongoing arrhythmia.An explanation as well as an enhancement of this issue was required.

Event Description

On (b)(6) 2016, a patient was admitted to the hospital because of an arrhythmic storm of shocks (25) and the patient was sedated.When the user clicked on the eps screen to deliver an atp therapy, a calibration issue occurred with the interface of the subject programmer involved into the interrogation.Therefore, a ventricular fibrillation (vf) induction was clicked instead of the atp and an external shock should have been delivered to reduce the ongoing arrhythmia.An explanation as well as an enhancement of this issue was required.

• Brand Name: ORCHESTRA
• Type of Device: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L. - CRM FACILITY; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140
• Manufacturer (Section G): KONTRON SUDETENSTR. 8 87600 KAUFBEUREN GERMANY; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140
• Manufacturer Contact: elodie vincent ; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140 ; 0146013665
• MDR Report Key: 5498626
• MDR Text Key: 40260673
• Report Number: 1000165971-2016-00158
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: PP980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ORCHESTRA PLUS
• Device Catalogue Number: ORCHESTRA PLUS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2016
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/04/2016
• Date Manufacturer Received: 03/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention