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 06/12/2018

Event Type  malfunction  

Event Description

It was reported that the subject programmer display only works properly at one specific angle (~40 degree).At other angles, the display distorts all the image.

Event Description

It was reported that the subject programmer display only works properly at one specific angle (~40 degree).At other angles, the display distorts all the image.

Manufacturer Narrative

Preliminary analysis suspects that the reported issue is due to a worn out video cable.

Event Description

It was reported that the subject programmer display only works properly at one specific angle (~40 degree).At other angles, the display distorts all the image.

Event Description

It was reported that the subject programmer display only works properly at one specific angle (~40 degree).At other angles, the display distorts all the image.

Manufacturer Narrative

The programmer was returned and will be analyzed.

Event Description

It was reported that the subject programmer display only works properly at one specific angle (~40 degree).At other angles, the display distorts all the image.

• 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: 7681058
• MDR Text Key: 113755820
• Report Number: 1000165971-2018-00633
• 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
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• 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: 01/08/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/12/2018
• Date Manufacturer Received: 01/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1