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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 Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Unexpected Shutdown (4019)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/08/2018
Event Type  malfunction  
Event Description
Reportedly, the programmer is very slow to turn on and suddenly switches off when interrogating devices.Moreover, the upper plastic part is broken.Preliminary analysis of the returned programmer showed that the reported shutdowns could not be reproduced.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Reportedly, the programmer is very slow to turn on and suddenly switches off when interrogating devices.Moreover, the upper plastic part is broken.Preliminary analysis of the returned programmer showed that the reported shutdowns could not be reproduced.
 
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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 Key7560529
MDR Text Key109907852
Report Number1000165971-2018-00530
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
Type of Report Initial,Followup
Report Date 07/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
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? Device Returned to Manufacturer
Date Returned to Manufacturer05/24/2018
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/11/2018
Event Location Hospital
Initial Date Manufacturer Received 05/11/2018
Initial Date FDA Received06/01/2018
Supplement Dates Manufacturer Received06/29/2018
Supplement Dates FDA Received07/16/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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