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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY PLATINIUM; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, CARDIAC RESYNCHRONIZATION
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SORIN GROUP ITALIA S.R.L. - CRM FACILITY PLATINIUM; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, CARDIAC RESYNCHRONIZATION Back to Search Results
Model Number PLATINIUM SONR CRT-D 1811
Device Problems Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem No Information (3190)
Event Date 03/11/2019
Event Type  malfunction  
Manufacturer Narrative
The device involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by sorin that was cleared or approved by fda for marketing in the united states.
 
Event Description
Reportedly, on (b)(6) 2019, a re-intervention was performed due to several inappropriate shocks caused by noise oversensing.The noise was confirmed in sensing tests.The associated ventricular lead was abandoned in the patient's body as a lead issue was suspected.The physician decided to replace the subject crt-d due to a battery longevity estimation value of less than 3 months.The crt-d only lasted 3 years with 15 charges, whereas an estimation of 5 years with the programmed parameters was given by the application.Based on preliminary analysis, a ventricular lead issue and/or lead/crt-d connection issue at ventricular level are suspected.
 
Event Description
Reportedly, on (b)(6)2019 , a re-intervention was performed due to several inappropriate shocks caused by noise oversensing.The noise was confirmed in sensing tests.The associated ventricular lead was abandoned in the patient's body as a lead issue was suspected.The physician decided to replace the subject crt-d due to a battery longevity estimation value of less than 3 months.The crt-d only lasted 3 years with 15 charges, whereas an estimation of 5 years with the programmed parameters was given by the application.Based on preliminary analysis, a ventricular lead issue and/or lead/crt-d connection issue at ventricular level are suspected.
 
Manufacturer Narrative
Please refer to the attached analysis report.
 
Event Description
Reportedly, on (b)(6) 2019, a re-intervention was performed due to several inappropriate shocks caused by noise oversensing.The noise was confirmed in sensing tests.The associated ventricular lead was abandoned in the patient's body as a lead issue was suspected.The physician decided to replace the subject crt-d due to a battery longevity estimation value of less than 3 months.The crt-d only lasted 3 years with 15 charges, whereas an estimation of 5 years with the programmed parameters was given by the application.Based on preliminary analysis, a ventricular lead issue and/or lead/crt-d connection issue at ventricular level are suspected.
 
Manufacturer Narrative
Based on preliminary analysis results, no issue is suspected on the battery.
 
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Brand Name
PLATINIUM
Type of Device
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, CARDIAC RESYNCHRONIZATION
Manufacturer (Section D)
SORIN GROUP ITALIA S.R.L. - CRM FACILITY
parc d'affaires noveos 4 avenue réaumur
.
clamart 92140
FR  92140
MDR Report Key8459822
MDR Text Key140609409
Report Number1000165971-2019-00173
Device Sequence Number1
Product Code NIK
UDI-Device Identifier08031527014388
UDI-Public(01)08031527014388(11)160516(17)171216
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup
Report Date 06/24/2019
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 Expiration Date12/16/2017
Device Model NumberPLATINIUM SONR CRT-D 1811
Device Catalogue NumberPLATINIUM SONR CRT-D 1811
Device Lot NumberS0180
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/03/2019
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/11/2019
Event Location Hospital
Initial Date Manufacturer Received 03/11/2019
Initial Date FDA Received03/28/2019
Supplement Dates Manufacturer Received05/03/2019
06/12/2019
Supplement Dates FDA Received05/21/2019
06/24/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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