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

Model Number ORCHESTRA PLUS

Device Problem Device Operational Issue (2914)

Patient Problem No Information (3190)

Event Date 05/24/2017

Event Type  malfunction  

Event Description

Reportedly, during a pacemaker check on (b)(6) 2017, an error in aida reading occurred due to displacement of the programming head.With the programming head placed over again, the pacemaker was re-interrogated.However, the aida reading process was unsuccessful.When the pacemaker was interrogated again, aida reading was successfully completed.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

Reportedly, during a pacemaker check on (b)(6) 2017, an error in aida reading occurred due to displacement of the programming head.With the programming head placed over again, the pacemaker was re-interrogated.However, the aida reading process was unsuccessful.When the pacemaker was interrogated again, aida reading was successfully completed.

• 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: 6649344
• MDR Text Key: 77830588
• Report Number: 1000165971-2017-00481
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Model Number: ORCHESTRA PLUS
• Device Catalogue Number: ORCHESTRA PLUS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/01/2017
• Event Location: Hospital
• Date Manufacturer Received: 06/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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