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

Model Number LNQ11

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pocket Erosion (2013)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

This information is based entirely on journal literature.This event occurred outside the us.All information provided is included in this report.Patient information is limited due to confidentiality concerns.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: ¿ejectable loop recorders? heart rhythm society.2016.Http://dx.Doi.Org/10.1016/j.Hrthm.2016.05.027.Concomitant medical products: remote home monitor.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was reviewed regarding this patient¿s implantable loop recorder (ilr).According to the article, fourteen weeks after implantation of the ilr, the patient activator no longer communicated and the remote monitor ¿abruptly stopped transmitting scheduled daily reports.¿ of note, four weeks prior, the patient underwent an ablation procedure.The patient indicated that there were no signs of infection or erosion, and denied any trauma to the device.The patient did mention that there was a small amount of blood at the insertion site two weeks after implantation, but only on one day.The incision site was ¿well healed.¿ the ilr could not be felt.A programmer was used to locate the device without success.The patient underwent a chest radio-graph which confirmed that the device was no longer at the implant site.Additional scans were done to ensure that the device had not migrated elsewhere.The status of the device is unknown.Additional information was obtained through follow up with the author who indicated that there were "no allegations or product specific complications." the author also indicated that there were no additional surgical/medical interventions taken and the patient is doing "well" and has not had any further issues related to this event.No patient complications have been reported 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: 6005154
• MDR Text Key: 56757741
• Report Number: 2182208-2016-02253
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K132649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 07/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2016
• 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: 07/09/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1249-2016
• Patient Sequence Number: 1
• Treatment: PATIENT ACTIVATOR
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR