SENTUS PROMRI OTW QP L-85/49 408719 SEE MODEL NO.

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-31 for SENTUS PROMRI OTW QP L-85/49 408719 SEE MODEL NO. manufactured by Biotronik Se & Co. Kg.

Event Text Entries

[185941074] This lead was explanted and replaced due to dislodgement. Should additional information become available, this file will be updated.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1028232-2020-01514
MDR Report Key9908702
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-31
Date of Report2020-03-27
Date of Event2019-12-03
Date Mfgr Received2020-03-27
Device Manufacturer Date2017-06-13
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer Street6024 JEAN ROAD
Manufacturer CityLAKE OSWEGO OR 97035
Manufacturer CountryUS
Manufacturer Postal97035
Manufacturer Phone8772459800
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSENTUS PROMRI OTW QP L-85/49
Generic NameLV LEAD
Product CodeOJX
Date Received2020-03-31
Model Number408719
Catalog NumberSEE MODEL NO.
Device Expiration Date2019-06-30
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerBIOTRONIK SE & CO. KG
Manufacturer AddressWOERMANNKEHRE 1 BERLIN 12359 DE 12359


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2020-03-31

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