SOLIA S 53 377177 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 SOLIA S 53 377177 SEE MODEL NO. manufactured by Biotronik Se & Co. Kg.

Event Text Entries

[185940692] 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 Number1028232-2020-01510
MDR Report Key9908695
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-31
Date of Report2020-03-25
Date of Event2020-03-25
Date Mfgr Received2020-03-25
Device Manufacturer Date2019-11-28
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 NameSOLIA S 53
Generic NamePACING LEAD
Product CodeNVN
Date Received2020-03-31
Model Number377177
Catalog NumberSEE MODEL NO.
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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