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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 Failure to Shut Off (2939); Delayed Program or Algorithm Execution (4034)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/05/2018
Event Type  malfunction  
Event Description
Reportedly, the programmer is too slow to perform an interrogation and does not shut down without using the log off.
 
Manufacturer Narrative
Please refer to the attached analysis report.- attachment: [20190128 - file-2018-03641 - analysis_and_closure_report_resp-2019-00105.Pdf].
 
Event Description
Reportedly, the programmer is too slow to perform an interrogation and does not shut down without using the log off.
 
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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 Key8100950
MDR Text Key128319982
Report Number1000165971-2018-01015
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 01/28/2019
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? Device Returned to Manufacturer
Date Returned to Manufacturer11/27/2018
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/05/2018
Initial Date Manufacturer Received 11/05/2018
Initial Date FDA Received11/26/2018
Supplement Dates Manufacturer Received01/18/2019
Supplement Dates FDA Received01/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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