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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. DUAL CHAMBER TEMPORARY PACEMAKER; PULSE-GENERATOR, PACEMAKER, EXTERNAL
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MEDTRONIC, INC. DUAL CHAMBER TEMPORARY PACEMAKER; PULSE-GENERATOR, PACEMAKER, EXTERNAL Back to Search Results
Model Number 5392
Device Problem Pacing Intermittently (1443)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/25/2024
Event Type  malfunction  
Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
Event Description
It was reported that the external pulse generator (epg) was unable to stimulate correctly.No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
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Brand Name
DUAL CHAMBER TEMPORARY PACEMAKER
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 Key18991107
MDR Text Key338983768
Report Number2182208-2024-01364
Device Sequence Number1
Product Code DTE
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K150246
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/28/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number5392
Device Catalogue Number5392
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/25/2024
Date Device Manufactured09/27/2017
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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