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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 Device Operates Differently Than Expected (2913); Operating System Becomes Nonfunctional (2996); Intermittent Communication Failure (4038)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/11/2018
Event Type  malfunction  
Event Description
It was reported that the cpr3 head intermittently failed to initialize leaving the programmer unable to interrogate.
 
Manufacturer Narrative
Please refer to the attached investigation report.
 
Event Description
It was reported that the cpr3 head intermittently failed to initialize leaving the programmer unable to interrogate.
 
Manufacturer Narrative
Please find attached an updated version of the investigation report.
 
Event Description
It was reported that the cpr3 head intermittently failed to initialize leaving the programmer unable to interrogate.
 
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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 Key7653234
MDR Text Key112846708
Report Number1000165971-2018-00630
Device Sequence Number0
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 company representative
Type of Report Initial,Followup,Followup
Report Date 01/09/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received06/29/2018
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? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/11/2018
Date Manufacturer Received01/09/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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