DBS LEAD KIT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-23 for DBS LEAD KIT manufactured by Medtronic.

MAUDE Entry Details

Report Number9224277
MDR Report Key9224277
Date Received2019-10-23
Date of Report2019-10-06
Date of Event2019-07-31
Report Date2019-10-06
Date Reported to FDA2019-10-06
Date Reported to Mfgr2019-10-23
Date Added to Maude2019-10-23
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDBS LEAD KIT
Generic NameDBS LEAD
Product CodeOLM
Date Received2019-10-23
Lot NumberVA1ZW6V
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age1 DA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC
Manufacturer Address710 MEDTRONIC PARKWAY MINNEAPOLIS MN 55432 US 55432


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-23

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