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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 Erratic or Intermittent Display (1182); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/13/2018
Event Type  malfunction  
Event Description
Reportedly, the problem with the subject programmer is that it does not boot-up into the smartview software and is therefore unusable.It only displays the sorin logo without displaying any windows or error messages.
 
Event Description
Reportedly, the problem with the subject programmer is that it does not boot-up into the smartview software and is therefore unusable.It only displays the sorin logo without displaying any windows or error messages.
 
Manufacturer Narrative
Please refer to the attached analysis report.
 
Manufacturer Narrative
Preliminary analysis revealed that the most likely root cause of the reported event is the corruption of hard disk's file system.
 
Event Description
Reportedly, the problem with the subject programmer is that it does not boot-up into the smartview software and is therefore unusable.It only displays the sorin logo without displaying any windows or error messages.
 
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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 Key7636885
MDR Text Key112310428
Report Number1000165971-2018-00602
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 12/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2018
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 Manufacturer09/10/2018
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/13/2018
Date Manufacturer Received11/16/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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