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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 Interrogation Problem (4017); Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/22/2020
Event Type  Malfunction  
Event Description

Reportedly, the screen freezes and they are communication problems between the subject programmer and pacemakers.

 
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Brand NameORCHESTRA
Type of DevicePROGRAMMER, PACEMAKER
Manufacturer (Section D)
SORIN GROUP ITALIA S.R.L. - CRM FACILITY
parc d'affaires noveos 4 avenue réaumur
.
clamart 92140
FR 92140
Manufacturer (Section G)
KONTRON SUDETENSTR. 8 87600 KAUFBEUREN GERMANY
parc d'affaires noveos 4 avenue réaumur
.
clamart 92140
FR 92140
Manufacturer Contact
laura ouaki
parc d'affaires noveos 4 avenue réaumur
.
clamart 92140
FR   92140
146013429
MDR Report Key10307747
MDR Text Key200816905
Report Number1000165971-2020-00518
Device Sequence Number1
Product Code KRG
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberP980049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 10/19/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/22/2020
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 Manufacturer08/17/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/26/2020
Event Location Hospital
Date Manufacturer Received10/01/2020
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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