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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY ORCHESTRA; PROGRAMMER, PACEMAKER
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SORIN GROUP ITALIA S.R.L. - CRM FACILITY ORCHESTRA; PROGRAMMER, PACEMAKER Back to Search Results
Model Number ORCHESTRA PLUS
Device Problems Interrogation Problem (4017); Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/11/2019
Event Type  malfunction  
Event Description
Reportedly, the software crashed suddenly and the user interface remained frozen, no action was possible.It was not possible to interrogate devices.Preliminary analysis of returned programmer did not confirm the reported event.However, it reveal that the etx board was not correctly plugged.
 
Manufacturer Narrative
Please refer to the attached analysis report.
 
Event Description
Reportedly, the software crashed suddenly and the user interface remained frozen, no action was possible.It was not possible to interrogate devices.Preliminary analysis of returned programmer did not confirm the reported event.However, it reveal that the etx board was not correctly plugged.
 
Manufacturer Narrative
Please refer to the updated analysis report.
 
Event Description
Reportedly, the software crashed suddenly and the user interface remained frozen, no action was possible.It was not possible to interrogate devices.Preliminary analysis of returned programmer did not confirm the reported event.However, it reveal that the etx board was not correctly plugged.
 
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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 Key8481704
MDR Text Key140932747
Report Number1000165971-2019-00189
Device Sequence Number1
Product Code KRG
Combination Product (y/n)N
PMA/PMN Number
P980049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup,Followup
Report Date 08/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberORCHESTRA PLUS
Device Catalogue NumberORCHESTRA PLUS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/15/2019
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/11/2019
Event Location Hospital
Date Manufacturer Received07/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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