LEAD ADAPTOR 501206

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-06-03 for LEAD ADAPTOR 501206 manufactured by Greatbatch Medical.

MAUDE Entry Details

Report Number2183787-2019-00048
MDR Report Key8663581
Report SourceDISTRIBUTOR
Date Received2019-06-03
Date of Report2019-05-07
Date of Event2019-04-15
Date Mfgr Received2019-05-07
Device Manufacturer Date2018-05-01
Date Added to Maude2019-06-03
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 ContactRHONDA STAGER
Manufacturer Street2360 BERKSHIRE LANE
Manufacturer CityPLYMOUTH MN 55441
Manufacturer CountryUS
Manufacturer Postal55441
Manufacturer Phone7639518376
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLEAD ADAPTOR
Generic NameBIPOLAR LEAD ADAPTOR
Product CodeDTD
Date Received2019-06-03
Model Number501206
Lot NumberW4336255
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerGREATBATCH MEDICAL
Manufacturer Address2360 BERKSHIRE LANE PLYMOUTH MN 55441 US 55441


Patients

Patient NumberTreatmentOutcomeDate
10 2019-06-03

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