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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 Intermittent Capture (1080)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/04/2022
Event Type  malfunction  
Event Description
It was reported that the external pulse generator (epg) was pacing intermittently.There was no patient involvement.
 
Manufacturer Narrative
Product analysis: field service analysis of the epg was unable to confirm the customer comment of intermittent pacing.The epg passed inspection check and testing with no problems found.If information is provided in the future, a supplemental report will be issued.
 
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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 Key13358059
MDR Text Key284458419
Report Number2182208-2022-00245
Device Sequence Number1
Product Code DTE
Combination Product (y/n)N
Reporter Country CodeMY
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 01/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2022
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 Received01/04/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/24/2017
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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