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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 Electrical /Electronic Property Problem (1198); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/13/2018
Event Type  malfunction  
Event Description
It was reported that the subject programmer failed leakage current tests because it outputting too much energy (reportedly: "2 ohms which is 4 times the limit").Tests made on the power cable and the programmer reportedly determined the cable is fine, the issue is the programmer.
 
Event Description
It was reported that the subject programmer failed leakage current tests because it outputting too much energy (reportedly : "2 ohms which is 4 times the limit").Tests made on the power cable and the programmer reportedly determined the cable is fine, the issue is the programmer.
 
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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 Key7653297
MDR Text Key113009833
Report Number1000165971-2018-00632
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
Report Date 05/14/2019
2 Devices were Involved in the Event: 1   2  
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 PLUS
Device Catalogue NumberORCHESTRA PLUS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/02/2018
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/13/2018
Initial Date Manufacturer Received 06/13/2018
Initial Date FDA Received06/29/2018
Supplement Dates Manufacturer Received04/19/2019
Supplement Dates FDA Received05/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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