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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 Interrogation Problem (4017)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/01/2018
Event Type  Malfunction  
Manufacturer Narrative

The company opened a capa to investigate late reporting issues. After a retrospective review, this complaint was found to be reportable to the us fda and is therefore reported now.

 
Event Description

Reportedly, the subject programmer displayed error messages during interrogation or when printing reports, which ended the interrogation sessions.

 
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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)
GESPAC 18, CHEMIN DES AULX CH-1228 GEN¿VE SWITZLERLAND
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 Key10244399
MDR Text Key198511861
Report Number1000165971-2020-00477
Device Sequence Number1
Product Code KRG
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP980049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial
Report Date 07/08/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/08/2020
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 Manufacturer01/23/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/01/2018
Event Location No Information
Date Manufacturer Received11/01/2018
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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