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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 PLUS; PROGRAMMER, PACEMAKER
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SORIN GROUP ITALIA S.R.L. - CRM FACILITY ORCHESTRA PLUS; PROGRAMMER, PACEMAKER Back to Search Results
Model Number ORCHESTRA PLUS
Device Problem Wireless Communication Problem (3283)
Patient Problem Insufficient Information (4580)
Event Date 11/02/2022
Event Type  malfunction  
Event Description
Reportedly, during the replacement of an icd, the device was interrogated and rf communication was lost.An error message appeared on the programmer screen, followed by two windows error messages.Another interrogation had to be performed in order to restore rf communication.
 
Event Description
Reportedly, during the replacement of an icd, the device was interrogated and rf communication was lost.An error message appeared on the programmer screen, followed by two windows error messages.Another interrogation had to be performed in order to restore rf communication.Preliminary analysis revealed that the issue most probably resulted from an incorrect positioning of the rf head.
 
Manufacturer Narrative
Preliminary analysis revealed that the issue most probably resulted from an incorrect positioning of the rf head.
 
Manufacturer Narrative
Please refer to the attached analysis report.
 
Event Description
Reportedly, during the replacement of an icd, the device was interrogated and rf communication was lost.An error message appeared on the programmer screen, followed by two windows error messages.Another interrogation had to be performed in order to restore rf communication.
 
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Brand Name
ORCHESTRA PLUS
Type of Device
PROGRAMMER, PACEMAKER
Manufacturer (Section D)
SORIN GROUP ITALIA S.R.L. - CRM FACILITY
parc d'affaires noveos
4 avenue reaumur
clamart 92140
FR  92140
Manufacturer (Section G)
KONTRON
sudetenstr. 8
kaufbeuren 87600
GM   87600
Manufacturer Contact
elodie vincent
parc d'affaires noveos
4 avenue reaumur
clamart 92140
FR   92140
MDR Report Key15892324
MDR Text Key305077081
Report Number1000165971-2022-00551
Device Sequence Number1
Product Code KRG
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P980049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 01/26/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2022
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? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/26/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient EthnicityNon Hispanic
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