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

Model Number LNQ11

Device Problem Energy Output Problem (1431)

Patient Problems Erosion (1750); Pocket Erosion (2013); Twiddlers Syndrome (2114); Blood Loss (2597)

Event Date 01/01/2016

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.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:.¿missing linq: extrusion of a new-generation implantable loop recorder in a child.¿ cardiology in the young 2016; pages 1-3.Doi:10.1017/s1047951116000913.

Event Description

A journal article was reviewed which contained information about this patient¿s implantable loop recorder.The article reported that an implantable loop recorder had been implanted in the patient.An initial transmission was sent on the fourth day post-procedure; and the device was functioning normally.On the ninth day after implant, the patient¿s family member reported being concerned about¿bleeding through the adhesive.¿ the bleeding improved and the patient was seen in the clinic twelve days after the device was implanted.The device was in place and the scar was healing.The patient¿s device was programmed to automatically send transmissions every 30 days.However, it was found that no transmissions were sent.The author noted that the patient¿s family member was ¿urged¿ to send manual transmissions, but did not after the initial test transmission.One-hundred twenty-two days after implant, an automatic transmission was sent.The patient¿s family member was contacted due to the ¿low-amplitude transmission.¿ the patient's family member informed the clinic that the device could no longer be felt in the patient¿s chest and that a transmission could not be completed.The patient was brought into the clinic 133 days after implant.The device could not be seen via an x-ray, and other imaging tests.A hand-held metal detector was also used with no detection of the device.Additionally, there was no data recorded in the device after day 33 post-implant.The author concluded that the device had eroded out of the pocket or was ¿physically removed by the patient.¿ the author also hypothesized that the device was in the home because it was able to send a transmission on day 122.The author indicated that after discussion with the patient¿s family and the physician, it was decided that a new device should be implanted; however, the patient¿s family ¿chose not to replace the device.¿ the status of the device is unknown.Further follow up did not yet yield any additional information.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Additional information: (b)(4).This device was reported as included in the field action.Based on the information received and without the return of the product, it cannot be confirmed that this device performed as described in the field action.It is included in the field action in the abundance of caution.

Event Description

A journal article was reviewed which contained information about this patient¿s implantable loop recorder.The article reported that an implantable loop recorder had been implanted in the patient.An initial transmission was sent on the fourth day post-procedure; and the device was functioning normally.On the ninth day after implant, the patient¿s family member reported being concerned about ¿bleeding through the adhesive.¿ the bleeding improved and the patient was seen in the clinic twelve days after the device was implanted.The device was in place and the scar was healing.The patient¿s device was programmed to automatically send transmissions every 30 days.However, it was found that no transmissions were sent.The author noted that the patient¿s family member was ¿urged¿ to send manual transmissions, but did not after the initial test transmission.One-hundred twenty-two days after implant, an automatic transmission was sent.The patient¿s family member was contacted due to the ¿low-amplitude transmission.¿ the patient's family member informed the clinic that the device could no longer be felt in the patient¿s chest and that a transmission could not be completed.The patient was brought into the clinic 133 days after implant.The device could not be seen via an x-ray, and other imaging tests.A hand-held metal detector was also used with no detection of the device.Additionally, there was no data recorded in the device after day 33 post-implant.The author concluded that the device had eroded out of the pocket or was ¿physically removed by the patient.¿ the author also hypothesized that the device was in the home because it was able to send a transmission on day 122.The author indicated that after discussion with the patient¿s family and the physician, it was decided that a new device should be implanted; however, the patient¿s family ¿chose not to replace the device.¿ the status of the device is unknown.Further follow up did not yet yield any additional information.No patient complications have been reported as a result of this event.

Event Description

Additional information was obtained through follow up with the author.The author indicated that there were "no allegations or product specific complications" against this manufacturer's products.The author also indicated that the article was written to suggest that even though training indicated that no suturing was required, the author found that when the device is implanted in children, the skin adhesive used might not be adequate.The author reported that when suturing was used, "no more issues" were seen.

• 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: 5819007
• MDR Text Key: 50325925
• Report Number: 2182208-2016-01796
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 09/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2016
• 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: 09/06/2016
• 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
• Patient Outcome(s): Required Intervention