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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 Problems Telemetry Discrepancy (1629); Device Operates Differently Than Expected (2913); Operating System Becomes Nonfunctional (2996); Interrogation Problem (4017)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/15/2018
Event Type  malfunction  
Event Description
It was reported that with the subject programmer, the cpr3 head did not initialize.
 
Manufacturer Narrative
Preliminary analysis did not reveal any issue on the subject programmer.
 
Event Description
It was reported that with the subject programmer, the cpr3 head did not initialize.
 
Event Description
It was reported that with the subject programmer, the cpr3 head did not initialize.
 
Manufacturer Narrative
(b)(4).
 
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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 Key7348023
MDR Text Key102863877
Report Number1000165971-2018-00273
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 company representative
Type of Report Initial,Followup,Followup
Report Date 07/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
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 Manufacturer06/08/2018
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/15/2018
Initial Date Manufacturer Received 03/15/2018
Initial Date FDA Received03/19/2018
Supplement Dates Manufacturer Received06/13/2018
07/19/2018
Supplement Dates FDA Received06/29/2018
07/26/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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