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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 Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Issue With Displayed Error Message (2967)
Patient Problem No Information (3190)
Event Date 05/27/2015
Event Type  malfunction  
Event Description
It was reported that during a pacemaker check, successful interrogation and tests were performed.However, a freeze occurred on a message.Upon rebooting the subject programming, the following message ¿head successfully initialised¿ was displayed and it was not possible to interrogate the pacemaker.The programmer on/off button was pressed several times and also the power cable was pulled out several times; however, the same message was displayed and it was still unable to interrogate the pacemaker.An explanation is required.
 
Event Description
It was reported that during a pacemaker check, successful interrogation and tests were performed.However, a freeze occurred on a message.Upon rebooting the subject programming, the following message ¿head successfully initialised¿ was displayed and it was not possible to interrogate the pacemaker.The programmer on/off button was pressed several times and also the power cable was pulled out several times; however, the same message was displayed and it was still unable to interrogate the pacemaker.An explanation is required.
 
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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
Manufacturer (Section G)
KONTRON SUDETENSTR. 8 87600 KAUFBEUREN GERMANY
parc d'affaires noveos 4 avenue réaumur
.
clamart 92140
FR   92140
Manufacturer Contact
elodie vincent
parc d'affaires noveos 4 avenue réaumur
.
clamart 92140
FR   92140
0146013665
MDR Report Key4874725
MDR Text Key6259606
Report Number1000165971-2015-00387
Device Sequence Number1
Product Code KRG
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
PP980049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 06/01/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2015
Is this a Product Problem Report? Yes
Device Operator Physician
Device Model NumberORCHESTRA PLUS
Device Catalogue NumberORCHESTRA PLUS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date06/01/2015
Event Location Hospital
Date Manufacturer Received08/05/2015
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
Patient Sequence Number1
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