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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 Problem Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem No Information (3190)
Event Date 06/24/2020
Event Type  malfunction  
Event Description
Reportedly, on (b)(6) 2020, during the follow-up, the message cancel operation was displayed and the subject orchestra plus was frozen.Ctrl, alt and delete keys were pushed and the password entered on windows security screen.Normal device behavior was restored.
 
Manufacturer Narrative
Please refer to the attached analysis report.
 
Event Description
Reportedly, on (b)(6) 2020, during the follow-up, the message cancel operation was displayed and the subject orchestra plus was frozen.Ctrl, alt and delete keys were pushed and the password entered on windows security screen.Normal device behavior was restored.
 
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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 Key10231748
MDR Text Key198107134
Report Number1000165971-2020-00471
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 health professional
Type of Report Initial,Followup
Report Date 09/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2020
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? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/25/2020
Event Location Hospital
Date Manufacturer Received09/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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