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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 Computer Software Problem (1112); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/27/2018
Event Type  malfunction  
Event Description
Reportedly, the software was not loading for the subject programmer.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Reportedly, the software was not loading for the subject programmer.
 
Manufacturer Narrative
Preliminary analysis of the programmer revealed that the reported behavior was due to system file corruption, which was resolved by re-ghosting the programmer.The root cause of this corruption could not be identified.
 
Event Description
Reportedly, the software was not loading for the subject programmer.
 
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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 Key7439771
MDR Text Key105919264
Report Number1000165971-2018-00387
Device Sequence Number1
Product Code MRM
Combination Product (y/n)N
PMA/PMN Number
P980049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup
Report Date 07/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2018
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 Manufacturer03/30/2018
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/27/2018
Event Location Hospital
Date Manufacturer Received07/03/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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