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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
Device Problems Calibration Problem (2890); Operating System Version or Upgrade Problem (2997)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/06/2018
Event Type  malfunction  
Event Description
Reportedly, the subject programmer cannot be upgraded to the new software version (smartview 2.56 ug1) since the currently installed software is too old (elaview 1.34 ug1).Moreover, the touchscreen is out of calibration.
 
Event Description
Reportedly, the subject programmer cannot be upgraded to the new software version (smartview 2.56 ug1) since the currently installed software is too old (elaview 1.34 ug1).Moreover, the touchscreen is out of calibration.
 
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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 Key8184077
MDR Text Key131339719
Report Number1000165971-2018-01087
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
Report Date 04/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberORCHESTRA
Device Catalogue NumberORCHESTRA
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/06/2018
Initial Date Manufacturer Received 12/06/2018
Initial Date FDA Received12/20/2018
Supplement Dates Manufacturer Received03/26/2019
Supplement Dates FDA Received04/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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