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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 04/18/2020
Event Type  malfunction  
Manufacturer Narrative
The device model involved in this mdr 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, the patient fell in his/her garden on (b)(6) 2020.The patient received two external shocks from the paramedics, and died before going to the hospital; therefore, there was no device interrogation performed post-death.It was also reported that a remote monitoring report was transmitted to the center two days before the patient death.Preliminary analysis of the provided files revealed a proper device functioning.Since no patient files are available for the time period surrounding the patient¿s death and the device was not returned for analysis, no further investigation can be performed.
 
Event Description
Reportedly, the patient fell in his/her garden on (b)(6) 2020.The patient received two external shocks from the paramedics, and died before going to the hospital; therefore, there was no device interrogation performed post-death.It was also reported that a remote monitoring report was transmitted to the center two days before the patient death.Preliminary analysis of the provided files revealed a proper device functioning.Since no patient files are available for the time period surrounding the patient¿s death and the device was not returned for analysis, no further investigation can be performed.
 
Manufacturer Narrative
Please refer to the attached analysis report.
 
Event Description
Reportedly, the patient fell in his/her garden on (b)(6) 2020.The patient received two external shocks from the paramedics, and died before going to the hospital; therefore, there was no device interrogation performed post-death.It was also reported that a remote monitoring report was transmitted to the center two days before the patient death.Preliminary analysis of the provided files revealed a proper device functioning.Since no patient files are available for the time period surrounding the patient¿s death and the device was not returned for analysis, no further investigation can be performed.
 
Manufacturer Narrative
Typo corrected (month and year missing in the conclusion of the analysis report).Please refer to the new attached analysis report.
 
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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 Key10201308
MDR Text Key197134392
Report Number1000165971-2020-00455
Device Sequence Number1
Product Code NIK
UDI-Device Identifier08031527014388
UDI-Public(01)08031527014388(11)190912(17)210412
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,study
Type of Report Initial,Followup,Followup
Report Date 08/03/2020
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 Date04/12/2021
Device Model NumberPLATINIUM SONR CRT-D 1811
Device Catalogue NumberPLATINIUM SONR CRT-D 1811
Device Lot NumberS0398
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/04/2020
Initial Date Manufacturer Received 06/04/2020
Initial Date FDA Received06/26/2020
Supplement Dates Manufacturer Received07/21/2020
08/03/2020
Supplement Dates FDA Received07/24/2020
08/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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