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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 04/17/2019
Event Type  malfunction  
Event Description
Reportedly, when the physician wanted to interrogate a pacemaker, the interrogation was not possible.The physician precised that it is one of the first interrogations after having the programmer in software version 3.00.Reportedly all leds were on as a standard interrogation; however, nothing occured after waiting several minutes.
 
Event Description
Reportedly, when the physician wanted to interrogate a pacemaker, the interrogation was not possible.The physician precised that it is one of the first interrogations after having the programmer in software version 3.00.Reportedly all leds were on as a standard interrogation; however, nothing occured after waiting several minutes.
 
Manufacturer Narrative
Preliminary analysis did not reveal any anomaly on the subject programmer.
 
Event Description
Reportedly, when the physician wanted to interrogate a pacemaker, the interrogation was not possible.The physician precised that it is one of the first interrogations after having the programmer in software version 3.00.Reportedly all leds were on as a standard interrogation; however, nothing occured after waiting several minutes.
 
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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 Key8581228
MDR Text Key144281469
Report Number1000165971-2019-00274
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 health professional
Type of Report Initial,Followup,Followup
Report Date 08/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2019
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 Manufacturer05/03/2019
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/17/2019
Date Manufacturer Received07/09/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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