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 2020-03-17 for REPLY REPLY DR manufactured by Sorin Group Italia S.r.l. - Crm Facility.

Event Text Entries

[183904940] Reportedly, during the subject device replacement due to normal battery depletion, evidences of pocket infection were observed. It was suspected that the infection was caused by the pacing system. It was decided then to cancel the replacement and to keep the pacing system implanted.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1000165971-2020-00308
MDR Report Key9842669
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-17
Date of Report2020-03-17
Date of Event2019-12-10
Date Facility Aware2019-12-12
Date Mfgr Received2019-12-12
Date Added to Maude2020-03-17
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 Received2020-03-17
Model NumberREPLY DR
Catalog NumberREPLY DR
Device Expiration Date2010-06-18
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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
101. Required No Informationntervention 2020-03-17

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