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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,WITH CRT-D
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SORIN GROUP ITALIA S.R.L. - CRM FACILITY PLATINIUM; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER,WITH CRT-D Back to Search Results
Model Number PLATINIUM CRT-D 1711
Device Problems Nonstandard Device (1420); No Apparent Adverse Event (3189)
Patient Problem No Information (3190)
Event Date 10/15/2018
Event Type  Injury  
Event Description
On (b)(6) 2018, the subject device was prophylactically replaced due to the fsn on platinium devices sent in (b)(6) 2018.The use of the subject device was discontinued and it was explanted from the patient¿s body.A new crt-d was connected to the implanted leads in use and the prophylactic crt-d replacement procedure was finished.
 
Manufacturer Narrative
Please refer to the attached analysis report.
 
Event Description
On (b)(6) 2018, the subject device was prophylactically replaced due to the fsn on platinium devices sent in (b)(6) 2018.The use of the subject device was discontinued and it was explanted from the patient¿s body.A new crt-d was connected to the implanted leads in use and the prophylactic crt-d replacement procedure was finished.
 
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Brand Name
PLATINIUM
Type of Device
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER,WITH CRT-D
Manufacturer (Section D)
SORIN GROUP ITALIA S.R.L. - CRM FACILITY
parc d'affaires noveos 4 avenue réaumur
.
clamart 92140
FR  92140
MDR Report Key8051169
MDR Text Key126555747
Report Number1000165971-2018-00974
Device Sequence Number0
Product Code NIK
PMA/PMN Number
P060027
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Remedial Action Recall
Type of Report Initial,Followup
Report Date 12/03/2018
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received11/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date12/31/2017
Device Model NumberPLATINIUM CRT-D 1711
Device Catalogue NumberPLATINIUM CRT-D 1711
Device Lot NumberS0187
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/16/2018
Event Location Hospital
Date Manufacturer Received11/20/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-2824-2018
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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