MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL REVEAL LINQ; DETECTOR AND ALARM, ARRHYTHMIA

Model Number LNQ11

Device Problems Migration or Expulsion of Device (1395); Invalid Sensing (2293); Positioning Problem (3009); Appropriate Term/Code Not Available (3191)

Patient Problems Syncope (1610); Dyspnea (1816); Undesired Nerve Stimulation (1980); Pain (1994); Shock (2072); Swelling (2091); No Code Available (3191)

Event Date 01/03/2017

Event Type  malfunction  

Manufacturer Narrative

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

It was reported that the implantable cardiac monitor (icm) patient's "left nipple swell(s) and will stick up and (the patient) will have to push the implant back down." it was also noted that the device "sends a shock to (the patient's) nipple." it was noted that the device does not come through the patient's skin.It was also reported that the patient has a "stabbing pain through (their) left nipple" when they lean down.The device remains in use.No further 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.

Event Description

The patient reported that they felt like the implantable cardiac monitor (icm) was "killing" them and also that, when the device was bumped, they had to urinate.They also stated that "the device is entangled with (their) nerves somehow," that their "blood pressure would spike.And then (they would) pass out." it was further reported that the device was defective and was not accurately detecting their heart rate.The device was explanted.

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.If information is provided in the future, a supplemental report will be issued.

Event Description

It was further reported that the patient's nipple started lactating and "when someone would touch (the patient's) nipple, (they) would defecate.".

Manufacturer Narrative

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

Event Description

It was further reported by the patient that there was ".Stuff (left) inside of (them and that).Little pieces (of) black stuff (are) coming out" of the patient's body.They also stated that they the device "caused permanent damage.Now (they) have a lymph chain thing, (that was) starting to invade (their) left lung and (that there were) nodules/nodes forming in (their) lungs." for which they will see a pulmonologist.It was also stated that they could "hardly breath(e)" and that the implant site still hurts.

Manufacturer Narrative

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

Event Description

It was further reported that the patient thought that the "doctor did not insert (the icm) correctly.".

Manufacturer Narrative

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

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 EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer Contact: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 6782348
• MDR Text Key: 82583637
• Report Number: 9614453-2017-03080
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00643169732216
• UDI-Public: 00643169732216
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/28/2017
• Device Model Number: LNQ11
• Device Catalogue Number: LNQ11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2016
• 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): Required Intervention
• Patient Age: 39 YR
• Patient Weight: 122