PLATINIUM PLATINIUM DR 1540

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-04 for PLATINIUM PLATINIUM DR 1540 manufactured by Sorin Group Italia S.r.l. - Crm Facility.

Event Text Entries

[182001648] Reportedly, upon device interrogation, the icd was found operating in nominal mode. No alert stating that a reset occurred was displayed. It seems that the physician saw the programmer screen becoming red in the corners and had validated a message stating that a safety mode will be programmed. The observed event may have resulted from an accidental press on the emergency button on the inductive programming head.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1000165971-2020-00250
MDR Report Key9665870
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-02-04
Date of Report2020-03-19
Date of Event2020-01-10
Date Facility Aware2020-01-10
Date Mfgr Received2020-03-04
Device Manufacturer Date2016-03-07
Date Added to Maude2020-02-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactLAURA OUAKI
Manufacturer StreetPARC D'AFFAIRES NOVEOS 4 AVENUE R .
Manufacturer CityCLAMART 92140
Manufacturer CountryFR
Manufacturer Postal92140
Manufacturer Phone146013429
Manufacturer G1SORIN GROUP ITALIA SRL VIA CRESCENTINO 13040 SALUGGIA ITALY
Manufacturer StreetPARC D'AFFAIRES NOVEOS 4 AVENUE R .
Manufacturer CityCLAMART 92140
Manufacturer CountryFR
Manufacturer Postal Code92140
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePLATINIUM
Generic NameDEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Product CodeMRM
Date Received2020-02-04
Model NumberPLATINIUM DR 1540
Catalog NumberPLATINIUM DR 1540
Lot NumberS0157
Device Expiration Date2017-10-07
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSORIN GROUP ITALIA S.R.L. - CRM FACILITY
Manufacturer AddressPARC D'AFFAIRES NOVEOS 4 AVENUE R?AUMUR . CLAMART 92140 FR 92140


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-04

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