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

Model Number ORCHESTRA PLUS

Device Problem Loss of Data (2903)

Patient Problem No Patient Involvement (2645)

Event Date 02/24/2015

Event Type  malfunction  

Event Description

Reportedly, on (b)(6) 2015, programmer software version was upgraded to 2.44j.After upgrade was completed, patient data saved in the programmer were checked; however many data were missing: patient data for ovatio, paradym 2 and opus g were still saved in the programmer and patient data for paradym, reply, reply 200, and symphony were all missing.Preliminary analysis showed that the loss of data is a consequence of a sudden shutdown of the machine that happened during database saving.In addition, on (b)(6) 2015 (one week post upgrade to 2.44j), when the programmer was activated, none of patient data was displayed neither on the patient data screen nor on the import/export screen.When some characters were entered in the bar ¿enter patient name or device serial number¿ on the top of programmer screen, data search was started and the data were displayed.When erasing all characters entered in that bar, all patient data were displayed.Preliminary analysis confirmed this behaviour and showed that it was related to a refresh issue.

Manufacturer Narrative

(b)(4).

Event Description

Reportedly, on (b)(6) 2015, programmer software version was upgraded to 2.44j.After upgrade was completed, patient data saved in the programmer were checked; however many data were missing: patient data for ovatio, paradym 2 and opus g were still saved in the programmer and patient data for paradym, reply, reply 200, and symphony were all missing.Preliminary analysis showed that the loss of data is a consequence of a sudden shutdown of the machine that happened during database saving.In addition, on (b)(6) 2015 (one week post upgrade to 2.44j), when the programmer was activated, none of patient data was displayed neither on the patient data screen nor on the import/export screen.When some characters were entered in the bar "enter patient name or device serial number" on the top of programmer screen, data search was started and the data were displayed.When erasing all characters entered in that bar, all patient data were displayed.Preliminary analysis confirmed this behaviour and showed that it was related to a refresh issue.

• 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 9214 0; FR 92140
• Manufacturer (Section G): KONTRON SUDETENSTR. 8 87600 KAUFBEUREN GERMANY; parc d'affaires noveos 4 avenue réaumur; .; clamart 9214 0; FR 92140
• Manufacturer Contact: elodie vincent ; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140 ; 0146013665
• MDR Report Key: 4641414
• MDR Text Key: 17998577
• Report Number: 1000165971-2015-00177
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PP980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2015
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2015
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/04/2015
• Event Location: Other
• Date Manufacturer Received: 04/09/2015
• Was Device Evaluated by Manufacturer?: No
• 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