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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 Problem Interrogation Problem (4017)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/01/2020
Event Type  Malfunction  
Event Description

Reportedly, during a follow-up, an error message was displayed upon interrogation of an icd. Analysis revealed that the programmer software module crashed, displaying the reported error message. The root cause of the crash could not be determined based on available data. It may have been due to corrupted system files or a programmer hardware issue. However, neither could be confirmed with certainty.

 
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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 Key10604588
MDR Text Key209443138
Report Number1000165971-2020-00616
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
Type of Report Initial,Followup
Report Date 10/16/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/30/2020
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? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/08/2020
Event Location Hospital
Date Manufacturer Received10/12/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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