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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 Noise, Audible (3273); Unexpected Shutdown (4019)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/09/2020
Event Type  malfunction  
Event Description
Reportedly, at the end of an interrogation session, while printing data, the programmer made a loud sound and the screen turned black, preventing the session from being ended properly.The programmer rebooted by itself.It was also reported that the patient is not pacing-dependent.
 
Manufacturer Narrative
Please refer to the attached analysis report.
 
Event Description
Reportedly, at the end of an interrogation session, while printing data, the programmer made a loud sound and the screen turned black, preventing the session from being ended properly.The programmer rebooted by itself.It was also reported that the patient is not pacing-dependent.
 
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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 Key10249785
MDR Text Key198693088
Report Number1000165971-2020-00493
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,health
Type of Report Initial,Followup
Report Date 09/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2020
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 Manufacturer06/30/2020
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/09/2020
Date Manufacturer Received09/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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