CARELINK 2490H

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-08-10 for CARELINK 2490H manufactured by Medtronic Milaca Inc..

Event Text Entries

[1095016] The patient reported that the carelink monitor would not turn on. When the patient went to remove the batteries, one battery leaked on the patient's hand causing blisters. The patient declined troubleshooting and stated she will not be using the monitor. No further patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


[1283185] (b) (4)
Patient Sequence No: 1, Text Type: D, B5


[8295236] The information submitted reflects all relevant data received. If additional relevant information is received, a supplemental report will be submitted. Analysis of the device is in process; the results will be forwarded when available.
Patient Sequence No: 1, Text Type: N, H10


[8431452] The information submitted reflects all relevant data received. If additional relevant information is received, a supplemental report will be submitted. Evaluation summary: (b) (4) visual analysis observed corrosion in the battery compartment. The monitor did not power up at initial testing due to the corrosion. During further analysis, the device passed full functional testing. The reported event could not be duplicated. Because batteries are not installed into the battery compartment in the assembly process, the corrosion was suspected to be induced externally.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2183613-2009-00014
MDR Report Key1434120
Report Source04
Date Received2009-08-10
Date Mfgr Received2009-06-09
Device Manufacturer Date2008-12-12
Date Added to Maude2010-02-09
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMARY FREY SR.MDR-VIGILANCE MGR
Manufacturer StreetCARDIAC RHYTHM DISEASE MGMT 8200 CORAL SEA ST. N.E.
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone7635260577
Single Use3
Previous Use Code3
Removal Correction NumberASKU
Event Type3
Type of Report3

Device Details

Brand NameCARELINK
Generic NamePATIENT MONITORING INSTRUMENT
Product CodeDXH
Date Received2009-08-10
Model Number2490H
Catalog NumberASKU
Lot NumberASKU
ID NumberASKU
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Age8 MO
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC MILACA INC.
Manufacturer Address900 SIXTH AVENUE NE ASKU MILACA MN 56353 US 56353


Patients

Patient NumberTreatmentOutcomeDate
150761. Other 2009-08-10

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