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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 Problem Structural Problem (2506)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/08/2019
Event Type  malfunction  
Event Description
Reportedly, the problem with the subject programmer is that the hinges for the storage compartment lid and upper case shell are cracked allowing the display screen and storage compartment lid to disconnect from the base.
 
Event Description
Reportedly, the problem with the subject programmer is that the hinges for the storage compartment lid and upper case shell are cracked allowing the display screen and storage compartment lid to disconnect from the base.
 
Manufacturer Narrative
Concomitant medical products and device evaluated by mfr updated.
 
Manufacturer Narrative
Please refer to the attached analysis report - attachment: [20190404 - file-2019-00066 - analysis_and_closure_report_resp-2019-00541.Pdf].
 
Event Description
Reportedly, the problem with the subject programmer is that the hinges for the storage compartment lid and upper case shell are cracked allowing the display screen and storage compartment lid to disconnect from the base.
 
Event Description
Reportedly, the problem with the subject programmer is that the hinges for the storage compartment lid and upper case shell are cracked allowing the display screen and storage compartment lid to disconnect from the base.
 
Manufacturer Narrative
Please refer to the attached anaysis report - attachment: [20190702 - file-2019-00066 - analysis_and_closure_report_resp-2019-00951.Pdf].
 
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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 Key8284097
MDR Text Key134327194
Report Number1000165971-2019-00051
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
Type of Report Initial,Followup,Followup,Followup
Report Date 07/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2019
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 Manufacturer06/07/2019
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/08/2019
Date Manufacturer Received07/02/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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