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

Model Number ORCHESTRA

Device Problem Operating System Becomes Nonfunctional (2996)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/13/2018

Event Type  malfunction  

Event Description

Reportedly, the message ¿operating system not found¿ is displayed when the subject programmer is powered on.The programmer does not boot and is not usable.

Event Description

Reportedly, the message ¿operating system not found¿ is displayed when the subject programmer is powered on.The programmer does not boot and is not usable.

Manufacturer Narrative

(b)(4).

• 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
• MDR Report Key: 7337261
• MDR Text Key: 102448653
• Report Number: 1000165971-2018-00250
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• PMA/PMN Number: P980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ORCHESTRA
• Device Catalogue Number: ORCHESTRA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Distributor Facility Aware Date: 02/13/2018
• Initial Date Manufacturer Received: 02/13/2018
• Initial Date FDA Received: 03/14/2018
• Supplement Dates Manufacturer Received: 03/19/2018
• Supplement Dates FDA Received: 04/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1