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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC.; ELECTRODE, PACEMAKER, TEMPORARY
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MEDTRONIC, INC.; ELECTRODE, PACEMAKER, TEMPORARY Back to Search Results
Model Number 5833SL
Device Problem High Capture Threshold (3266)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/01/2019
Event Type  malfunction  
Manufacturer Narrative
Product analysis: the complaint could not be confirmed.The cable passed visual inspection and electrical testing.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient cable exhibited undefined high thresholds, with multiple leads.The cable was returned for analysis.No patient complications have been reported as a result of this event.
 
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Brand Name
NA
Type of Device
ELECTRODE, PACEMAKER, TEMPORARY
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
lisa robertson
8200 coral sea st ne
mounds view, MN 55112
7635262723
MDR Report Key8556409
MDR Text Key143280606
Report Number2182208-2019-00797
Device Sequence Number1
Product Code LDF
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K923407
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number5833SL
Device Catalogue Number5833SL
Device Lot Number694200001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/09/2019
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/01/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/18/2018
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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