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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MILACA, INC.; PULSE-GENERATOR, PACEMAKER, EXTERNAL
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MEDTRONIC MILACA, INC.; PULSE-GENERATOR, PACEMAKER, EXTERNAL Back to Search Results
Model Number 5318
Device Problem Impedance Problem (2950)
Patient Problem No Patient Involvement (2645)
Event Date 03/13/2017
Event Type  malfunction  
Manufacturer Narrative
Product event summary: analysis found that there was something sticky on the battery contact chips.The machine worked normally.As a result the battery contact chips were cleaned and then the device was functionally tested.The device passed functional testing.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 it was not possible to measure impedance.The external pulse generator (epg) was returned for servicing.There was no patient involvement.
 
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Type of Device
PULSE-GENERATOR, PACEMAKER, EXTERNAL
Manufacturer (Section D)
MEDTRONIC MILACA, INC.
900 sixth avenue ne
milaca MN 56353 3728
Manufacturer (Section G)
MEDTRONIC MILACA, INC.
900 sixth avenue ne
milaca MN 56353 3728
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key6630245
MDR Text Key77224308
Report Number2183613-2017-00136
Device Sequence Number1
Product Code DTE
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K971474
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 03/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number5318
Device Catalogue Number5318
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/20/2017
Is the Reporter a Health Professional? No
Date Manufacturer Received03/20/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/17/2010
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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