Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MILACA, INC.; PULSE-GENERATOR, PACEMAKER, EXTERNAL
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC MILACA, INC.; 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 06/05/2018
Event Type  malfunction  
Manufacturer Narrative
Product analysis: analysis found that in the resistance test, the external resistor was set to 3320 ohms but the machine detected 500 ohms.The device was returned to the customer unrepaired.If information is provided in the future, a supplemental report will be issued.
 
Event Description
The external pulse generator (epg) was returned to the manufacturer for inspection.It was analyzed and tested out of specification.There was no patient involvement.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7643839
MDR Text Key112553143
Report Number2183613-2018-00152
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
Reporter Occupation Other
Type of Report Initial
Report Date 06/27/2018
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 Health Professional
Device Model Number5318
Device Catalogue Number5318
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/18/2018
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/05/2018
Initial Date FDA Received06/27/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-