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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MILACA, INC. EXTERNAL TEMPORARY PACEMAKER / IMPLANT TOOL MODEL; PULSE-GENERATOR, PACEMAKER, EXTERNAL
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MEDTRONIC MILACA, INC. EXTERNAL TEMPORARY PACEMAKER / IMPLANT TOOL MODEL; PULSE-GENERATOR, PACEMAKER, EXTERNAL Back to Search Results
Model Number 5318
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem No Patient Involvement (2645)
Event Date 06/14/2019
Event Type  malfunction  
Manufacturer Narrative
Product analysis: during analysis, it was observed that the external pulse generator (epg) shutdown immediately when the battery was removed.The printed circuit board (pcb) assembly was replaced.The device passed all final functional tests.If information is provided in the future, a supplemental report will be issued.
 
Event Description
The external pulse generator was returned to the company service department with a request for evaluation and subsequently tested out of specification during manufacturer's analysis.There was no patient involvement.
 
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Brand Name
EXTERNAL TEMPORARY PACEMAKER / IMPLANT TOOL MODEL
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
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key8818202
MDR Text Key151939674
Report Number2183613-2019-00122
Device Sequence Number1
Product Code DTE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K971474
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 07/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2019
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 Manufacturer06/14/2019
Date Manufacturer Received07/12/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/17/2007
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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