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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 2090AA
Device Problems Device Emits Odor (1425); Power Problem (3010)
Patient Problem No Patient Involvement (2645)
Event Date 11/04/2016
Event Type  malfunction  
Manufacturer Narrative
Product event summary: analysis confirmed the reported issue; there was black smoke and an electrical smell coming from the power supply.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during an interrogation there was an electrical smell and the programmer shut off.The programmer has been returned for service.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
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key6319483
MDR Text Key67126331
Report Number2182208-2017-00282
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 Other
Type of Report Initial
Report Date 11/04/2016
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 Manufacturer11/08/2016
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/04/2016
Initial Date FDA Received02/09/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/25/2003
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
(B)(4) RF HEAD
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