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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. CARELINK; PROGRAMMER, PACEMAKER
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MEDTRONIC, INC. CARELINK; PROGRAMMER, PACEMAKER Back to Search Results
Model Number 2067L
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Patient Involvement (2645)
Event Date 03/19/2019
Event Type  malfunction  
Manufacturer Narrative
Product event summary: manufacturer's analysis found that the radio frequency (rf) programmer head failed incoming functional testing due to excessive internal corrosion.The rf head was scrapped.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the radiofrequency programmer head, originally returned due to an interrogation issue, subsequently tested out of specification during manufacturer¿s analysis.There was no patient involvement.
 
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Brand Name
CARELINK
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
lisa robertson
8200 coral sea st ne
mounds view, MN 55112
7635262723
MDR Report Key8475149
MDR Text Key140669906
Report Number2182208-2019-00631
Device Sequence Number1
Product Code KRG
UDI-Device Identifier00613994435125
UDI-Public00613994435125
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 04/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number2067L
Device Catalogue Number2067L
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/08/2019
Date Manufacturer Received03/19/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/28/2011
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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