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 Not Applicable (3189)

Event Date 10/27/2015

Event Type  malfunction  

Event Description

A problem with the displayed implantation date of the pacemakers in orchestra plus was observed from the last upgrade 2.48.From one hand, in the manager module, the rhapsody, symphony pacemakers have incorrect implantation date (31/12/9999).From another hand, it was observed that kora 100 pacemakers have incorrect implantation date too: the last follow-up date was displayed instead of the implantation date.These erroneous dates appear only when the patient date is written as xxxxx but not when the correct name is written.An investigation is required.

Manufacturer Narrative

Preliminary analysis showed that having the follow-up date as an implantation date when no patient data are programmed is the intended behavior.However, the (b)(6) 1999 date observed is a display anomaly that concerns the symphony devices family.

Event Description

A problem with the displayed implantation date of the pacemakers in orchestra plus was observed from the last upgrade 2.48.From one hand, in the manager module, the rhapsody, symphony pacemakers have incorrect implantation date ((b)(6) 9999).From another hand, it was observed that kora 100 pacemakers have incorrect implantation date too: the last follow-up date was displayed instead of the implantation date.These erroneous dates appear only when the patient date is written as xxxxx but not when the correct name is written.An investigation is required.

Manufacturer Narrative

Please refer to the attached analysis report.(b)(4).

Event Description

A problem with the displayed implantation date of the pacemakers in orchestra plus was observed from the last upgrade 2.48.From one hand, in the manager module, the rhapsody, symphony pacemakers have incorrect implantation date (31/12/9999).From another hand, it was observed that kora 100 pacemakers have incorrect implantation date too: the last follow-up date was displayed instead of the implantation date.These erroneous dates appear only when the patient date is written as xxxxx but not when the correct name is written.An investigation is 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: 5242109
• MDR Text Key: 32157282
• Report Number: 1000165971-2015-00699
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2015
• 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?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/27/2015
• Event Location: Hospital
• Date Manufacturer Received: 01/25/2016
• 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