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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MILACA, INC. DUAL CHAMBER TEMPORARY PACEMAKER; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
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MEDTRONIC MILACA, INC. DUAL CHAMBER TEMPORARY PACEMAKER; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) Back to Search Results
Model Number 5388
Device Problems Power Problem (3010); Unexpected Shutdown (4019)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/04/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that when the external pulse generator (epg) was on and the battery was then removed, the time taken for the epg to shut off was inconsistent from 0-10 seconds.No patient complications have been reported as a result of this event.
 
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Brand Name
DUAL CHAMBER TEMPORARY PACEMAKER
Type of Device
IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
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 Key12092355
MDR Text Key259150230
Report Number2183613-2021-00074
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 health professional
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 06/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/1999
Device Model Number5388
Device Catalogue Number5388
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/04/2021
Date Device Manufactured08/04/1997
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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