MAUDE Adverse Event Report: MEDTRONIC, INC. REVEAL LINQ; DETECTOR AND ALARM, ARRHYTHMIA

Model Number LNQ11

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erythema (1840); Unspecified Infection (1930); Pain (1994); Perforation (2001); Blood Loss (2597); Fluid Discharge (2686)

Event Date 01/01/2015

Event Type  Injury  

Manufacturer Narrative

This information is based entirely on journal literature.All information provided is included in this report.Patient information is limited due to confidentiality concerns.Multiple patients were noted in the article; however, a one to one correlation could not be made with unique device serial numbers.The baseline gender/age of the patients is male/(b)(6).Request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Since no device id was provided, it is unknown if this event has been previously reported.Referenced article: safety profile of a miniaturized insertable cardiac monitor: results from two prospective trials.Pace pacing and clinical electrophysiology.2015;38(12):1464-1469.

Event Description

A journal article was reviewed that contained information regarding implantable cardiac monitors (icms).Multiple patients were noted in the article; however, a one to one correlation could not be made with unique device serial numbers.The article reports there were patients who experienced insertion site "superficial wound" infections which did not require treatment, and "minor" bleeding from the insertions site which stopped with applied pressure.There were also patient who experienced insertion site pain; in which some patients had the icm removed.In one patient, a "clear fluid emanated" from the wound, which the physician indicated was not an infection and the icm remained in use.There were two patients who had insertion site infections; one of which also had "mild erythema" and was resolved with antibiotics and one patient whose insertion site was drained and the device was explanted.The article also indicated that there was one patient who experienced pain at the insertion site, which progressed to a "perforation and spontaneous device explant through the insertion site." the status of all the icms is unknown.No further patient complications have been re ported as a result of this event.

Manufacturer Narrative

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

• 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
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5711147
• MDR Text Key: 47091999
• Report Number: 2182208-2016-01435
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: LNQ11
• Device Catalogue Number: LNQ11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR