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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 Interrogation Problem (4017)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/04/2020
Event Type  malfunction  
Event Description
Reportedly, several pop-up windows appeared during device's interrogation.The physician clicked ok on each message until the following message appeared: an invalid argument was encountered.The programmer was tested, after a message asking to reposition the head, the pacemaker interrogation was correctly performed.After a windows reboot, no problem was identified.However, it was impossible to reinstall software version 2.03.The physician then interrogated an icd, and the previously displayed message appeared.The programmer and the cpr3 head have been changed.
 
Manufacturer Narrative
Preliminary analysis revealed a possible hard disk corruption.Re-installation of the smartview software will be performed.
 
Event Description
Reportedly, several pop-up windows appeared during device's interrogation.The physician clicked ok on each message until the following message appeared: an invalid argument was encountered.The programmer was tested, after a message asking to reposition the head, the pacemaker interrogation was correctly performed.After a windows reboot, no problem was identified.However, it was impossible to reinstall software version 2.03.The physician then interrogated an icd, and the previously displayed message appeared.The programmer and the cpr3 head have been changed.
 
Event Description
Reportedly, several pop-up windows appeared during device's interrogation.The physician clicked ok on each message until the following message appeared: an invalid argument was encountered.The programmer was tested, after a message asking to reposition the head, the pacemaker interrogation was correctly performed.After a windows reboot, no problem was identified.However, it was impossible to reinstall software version 3.02.The physician then interrogated an icd, and the previously displayed message appeared.The programmer and the cpr3 head have been changed.
 
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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 Key10193673
MDR Text Key196764466
Report Number1000165971-2020-00448
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 company representative,health
Type of Report Initial,Followup,Followup
Report Date 10/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2020
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? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2020
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/04/2020
Date Manufacturer Received10/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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