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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. EXTERNAL TEMPORARY PACEMAKER / IMPLANT TOOL MODEL; PULSE-GENERATOR, PACEMAKER, EXTERNAL
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MEDTRONIC, 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 01/10/2020
Event Type  malfunction  
Manufacturer Narrative
Product analysis: manufacturer's analysis indicated that the epg sensing tested out of specification.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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Brand Name
EXTERNAL TEMPORARY PACEMAKER / IMPLANT TOOL MODEL
Type of Device
PULSE-GENERATOR, PACEMAKER, EXTERNAL
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer (Section G)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key10362709
MDR Text Key201554788
Report Number2182208-2020-01422
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 08/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/04/2020
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 Manufacturer01/13/2020
Date Manufacturer Received07/27/2020
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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