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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 Inaccurate Information (4051)
Patient Problem No Patient Involvement (2645)
Event Date 08/28/2020
Event Type  malfunction  
Event Description
Reportedly, during a smartview programmer software upgrade, it was observed that the serial number displayed on the programmer screen was different from the serial number displayed on the labeling.Preliminary analysis results showed that the reported issue resulted from a wrong manipulation during a previous repair.
 
Manufacturer Narrative
H3: preliminary analysis results had shown that the reported issue resulted from a wrong manipulation during a previous repair.The programmer was returned to microport crm to correct this issue; no expertise of the returned device was deemed necessary.Please refer to the analysis report.
 
Event Description
Reportedly, during a smartview programmer software upgrade, it was observed that the serial number displayed on the programmer screen was different from the serial number displayed on the labeling.Preliminary analysis results showed that the reported issue resulted from a wrong manipulation during a previous repair.
 
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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 Key10591902
MDR Text Key209343700
Report Number1000165971-2020-00612
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,other
Type of Report Initial,Followup
Report Date 12/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberORCHESTRA PLUS
Device Catalogue NumberORCHESTRA PLUS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/09/2020
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/31/2020
Event Location Hospital
Date Manufacturer Received12/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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