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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. REVEAL LINQ MOBILE MANAGER APP DETECTOR AND ALARM, ARRHYTHMIA

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MEDTRONIC, INC. REVEAL LINQ MOBILE MANAGER APP DETECTOR AND ALARM, ARRHYTHMIA Back to Search Results
Model Number LMM-GENERAL
Device Problem Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/20/2021
Event Type  Malfunction  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was reported that during the implant procedure, the implantable cardiac monitor (icm) was unable to be identified using the diagnostic mobile programmer application. The application was closed and when interrogating exhibited an electrical reset. It was noted that electrocautery was used several times during the procedure. The icm was reprogrammed and the diagnostic mobile programmer application remains in use. No patient complications have been reported as a result of this event.

 
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Brand NameREVEAL LINQ MOBILE MANAGER APP
Type of DeviceDETECTOR AND ALARM, ARRHYTHMIA
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 Key11265068
MDR Text Key229818741
Report Number2182208-2021-00467
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK150614
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/06/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/02/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberLMM-GENERAL
Device Catalogue NumberLMM-GENERAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/11/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 02/02/2021 Patient Sequence Number: 1
Treatment
ICM LNQ22 LINQ II
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