REPLY REPLY DR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-23 for REPLY REPLY DR manufactured by Sorin Group Italia S.r.l. - Crm Facility.

Event Text Entries

[184639157] The physician reported that the subject pacemaker was non functional after external defibrillation.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1000165971-2020-00325
MDR Report Key9868791
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-23
Date of Report2020-03-23
Date of Event2020-01-31
Date Facility Aware2020-02-27
Date Mfgr Received2020-02-27
Date Added to Maude2020-03-23
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 NameREPLY
Generic NamePULSE GENERATOR, PERMANENT, IMPLANTABLE
Product CodeDXY
Date Received2020-03-23
Returned To Mfg2020-03-04
Model NumberREPLY DR
Catalog NumberREPLY DR
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
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
101. Required No Informationntervention 2020-03-23

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