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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 Display or Visual Feedback Problem (1184); Application Program Problem (2880)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/19/2019
Event Type  malfunction  
Event Description
Reportedly, the subject programmer is not functioning well.A white screen was displayed after launching a pacemaker interrogation.
 
Manufacturer Narrative
Please refer to the attached analysis report.- attachment: [20200226 - file-2019-03983 - analysis_and_closure_report_resp-2020-00144.Pdf].
 
Event Description
Reportedly, the subject programmer is not functioning well.A white screen was displayed after launching a pacemaker interrogation.
 
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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 Key9452618
MDR Text Key177206087
Report Number1000165971-2019-00680
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 health professional,user faci
Type of Report Initial,Followup
Report Date 02/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2019
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 Manufacturer11/26/2019
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/19/2019
Event Location Hospital
Date Manufacturer Received02/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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