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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MILACA, INC.; PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
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MEDTRONIC MILACA, INC.; PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE Back to Search Results
Model Number 5388
Device Problem Contamination (1120)
Patient Problem No Patient Involvement (2645)
Event Date 01/04/2019
Event Type  malfunction  
Manufacturer Narrative
Product analysis: manufacturer's analysis indicated that the external pulse generator (epg) had contaminated battery contacts and a broken cover.The epg was repaired and returned to use.If information is provided in the future, a supplemental report will be issued.
 
Event Description
The external pulse generator (epg) was returned for testing and calibration and subsequently tested out of specification during manufacturer's analysis.There was no patient involvement.
 
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Type of Device
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
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
lisa robertson
8200 coral sea st ne
mounds view, MN 55112
7635262723
MDR Report Key8297614
MDR Text Key134869337
Report Number2183613-2019-00022
Device Sequence Number1
Product Code LWP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P820003
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 02/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number5388
Device Catalogue Number5388
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/14/2019
Date Manufacturer Received02/01/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/30/2004
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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