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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 Version or Upgrade Problem (2881)
Patient Problem No Patient Involvement (2645)
Event Date 06/01/2017
Event Type  malfunction  
Event Description
Reportedly, it was impossible to update the programmer with the clinical software.We have waited for 30 minutes before shutting down the programmer.A new update has been done 1 hour after without any issue.
 
Event Description
Reportedly, it was impossible to update the programmer with the clinical software.We have waited for 30 minutes before shutting down the programmer.A new update has been done 1 hour after without any issue.
 
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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
Manufacturer (Section G)
KONTRON SUDETENSTR. 8 87600 KAUFBEUREN GERMANY
parc d'affaires noveos 4 avenue réaumur
.
clamart 92140
FR   92140
Manufacturer Contact
elodie vincent
parc d'affaires noveos 4 avenue réaumur
.
clamart 92140
FR   92140
0146013665
MDR Report Key7012109
MDR Text Key92593507
Report Number1000165971-2017-00836
Device Sequence Number1
Product Code KRG
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P980049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,study
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2017
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
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/13/2017
Date Manufacturer Received12/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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