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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC CARELINK PROGRAMMER WITH ANALYZER; PROGRAMMER, PACEMAKER
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MEDTRONIC, INC. MEDTRONIC CARELINK PROGRAMMER WITH ANALYZER; PROGRAMMER, PACEMAKER Back to Search Results
Model Number 2090AA
Device Problem Corroded (1131)
Patient Problem No Patient Involvement (2645)
Event Date 07/11/2017
Event Type  malfunction  
Manufacturer Narrative
Product analysis: it was determined at analysis that the programmer had internal and external corrosion.Analysis also noted that the programmer powers up to an error.The programmer was scrapped and discarded.If information is provided in the future, a supplemental report will be issued.
 
Event Description
The programmer was returned as part of an inventory reduction initiative and subsequently tested out of specification during manufacturer's analysis.There was no patient involvement.
 
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Brand Name
MEDTRONIC CARELINK PROGRAMMER WITH ANALYZER
Type of Device
PROGRAMMER, PACEMAKER
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer (Section G)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key10216647
MDR Text Key197544926
Report Number2182208-2020-01184
Device Sequence Number1
Product Code KRG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P890003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 07/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number2090AA
Device Catalogue Number2090AA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/20/2020
Initial Date Manufacturer Received 06/01/2020
Initial Date FDA Received07/01/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/26/2003
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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