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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 Information (3190)
Event Date 12/09/2019
Event Type  malfunction  
Event Description
Reportedly, the subject programmer takes a long time to interrogate a device and then freezes.
 
Manufacturer Narrative
The reported behavior could not be reproduced during the expertise of the programmer.However, display issues due to a worn out cable were observed.
 
Event Description
Reportedly, the subject programmer takes a long time to interrogate a device and then freezes.
 
Event Description
Reportedly, the subject programmer takes a long time to interrogate a device and then freezes.
 
Manufacturer Narrative
Please refer to attached analysis report.
 
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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 Key9534587
MDR Text Key177185195
Report Number1000165971-2019-00746
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
Type of Report Initial,Followup,Followup
Report Date 05/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2019
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 Manufacturer01/07/2020
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/09/2019
Date Manufacturer Received05/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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