INLEXA 3 VR-T DF-1 404703 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,foreig report with the FDA on 2020-02-06 for INLEXA 3 VR-T DF-1 404703 SEE MODEL NO. manufactured by Biotronik Se & Co. Kg.

Event Text Entries

[182565470] After an implantation period of approx. 7 months, it was reported that during a testing of the device, a vt was triggered that was below the programmed threshold. The device could no longer be interrogated. The patient was defibrillated externally. The device was explanted.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1028232-2020-00603
MDR Report Key9676459
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-02-06
Date of Report2020-01-22
Date of Event2020-01-15
Date Mfgr Received2020-02-05
Device Manufacturer Date2018-12-12
Date Added to Maude2020-02-06
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 NameINLEXA 3 VR-T DF-1
Product CodeMRM
Date Received2020-02-06
Returned To Mfg2020-01-24
Model Number404703
Catalog NumberSEE MODEL NO.
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
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 2020-02-06

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