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

Model Number ORCHESTRA PLUS

Device Problem Erratic or Intermittent Display (1182)

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

Event Date 02/06/2018

Event Type  malfunction  

Event Description

It was reported that the subject programmer screen can intermittently become unreadable by showing only a solid white/gray/pink color, abnormal colors and/or lines across the screen.

Manufacturer Narrative

Please refer to the analysis report.

Event Description

It was reported that the subject programmer screen can intermittently become unreadable by showing only a solid white/gray/pink color, abnormal colors and/or lines across the screen.

Manufacturer Narrative

Preliminary analysis suspects a damage on the screen flex.

Event Description

It was reported that the subject programmer screen can intermittently become unreadable by showing only a solid white/gray/pink color, abnormal colors and/or lines across the screen.

• 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: 7266049
• MDR Text Key: 100148735
• Report Number: 1000165971-2018-00169
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 05/25/2018

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 PLUS
• Device Catalogue Number: ORCHESTRA PLUS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/06/2018
• Initial Date Manufacturer Received: 02/06/2018
• Initial Date FDA Received: 02/13/2018
• Supplement Dates Manufacturer Received: 02/07/2018; 05/25/2018
• Supplement Dates FDA Received: 02/15/2018; 05/25/2018
• 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