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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
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 08/25/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the entire system was explanted due to infection on (b)(6) 2017.An investigation is required.
 
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Brand Name
PLATINIUM
Common Device Name
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 Key7027692
Report Number1000165971-2017-00839
Device Sequence Number1051202
Product Code NIK
UDI-Device Identifier08031527015538
UDI-Public(01)08031527015538(11)160707(17)180207
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P060027
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date02/07/2018
Device Model NumberPLATINIUM CRT-D 1711
Device Catalogue NumberPLATINIUM CRT-D 1711
Device Lot NumberS0198
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/16/2017
Event Location Hospital
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/16/2017
Initial Report FDA Received Date11/14/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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