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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. REVEAL LINQ¿; DETECTOR AND ALARM, ARRHYTHMIA
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MEDTRONIC, INC. REVEAL LINQ¿; DETECTOR AND ALARM, ARRHYTHMIA Back to Search Results
Model Number LNQ11
Patient Problems Wound Dehiscence (1154); Fall (1848); Pain (1994)
Event Date 09/16/2023
Event Type  malfunction  
Event Description
The patient has the reveal linq insertable cardiac monitor placed a few days before.Patient sustained a fall from the cart to the floor immediately following the procedure on the opposite side that the device was placed.Patient felt a strong jarring due to the fall.The patient was discharged home.Patient noticed a lump and pain at the site where the implantable loop recorder was placed, returned to the emergency department (ed).Md found the reveal linq insertable cardiac monitor partially exposed through the chest, wound dehiscence, no drainage or bleeding.The reveal linq insertable cardiac monitor was removed without difficulty and disposed of in medical waste.Patient felt better upon removal of device.
 
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Brand Name
REVEAL LINQ¿
Type of Device
DETECTOR AND ALARM, ARRHYTHMIA
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
MDR Report Key17867753
MDR Text Key324905480
Report Number17867753
Device Sequence Number1
Product Code DSI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 09/29/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberLNQ11
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/29/2023
Date Report to Manufacturer10/04/2023
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age28835 DA
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