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 2020-03-31 for CARELINK PROGRAMMER 2090 manufactured by Medtronic, Inc..

Event Text Entries

[187206090] Product analysis: analysis was unable to confirm the customer comment that the programmer would not power on. It was noted that the touch screen malfunctioned and the stylus was out of calibration. The stylus assembly was calibrated and the device passed functional tests. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10

[187206091] It was reported that the programmer would not power on. The programmer was returned for service. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number2182208-2020-00636
MDR Report Key9908390
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-24
Date Mfgr Received2020-03-27
Device Manufacturer Date2012-02-28
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
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactPAULA BIXBY
Manufacturer Street8200 CORAL SEA ST NE
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone7635055378
Manufacturer G1MEDTRONIC, INC.
Manufacturer Street8200 CORAL SEA STREET NE
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal Code55112
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Product CodeKRG
Date Received2020-03-31
Returned To Mfg2020-03-26
Model Number2090
Catalog Number2090
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC, INC.
Manufacturer Address8200 CORAL SEA STREET NE MOUNDS VIEW MN 55112 US 55112


Patient NumberTreatmentOutcomeDate
10 2020-03-31

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