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

Model Number LNQ11

Device Problems Nonstandard Device (1420); Manufacturing, Packaging or Shipping Problem (2975); Appropriate Term/Code Not Available (3191)

Patient Problems Syncope (1610); Death (1802); Pain (1994); Seizures (2063); Skull Fracture (2077); Injury (2348)

Event Date 07/17/2016

Event Type  Death  

Manufacturer Narrative

Non-healthcare professional 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.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 sustained "serious, painful and permanent injuries" which caused the patient "to endure great pain and suffering" due to the icm being "negligently, carelessly, and recklessly designed, manufactured, imported, distributed and sold".It was further reported that the device "deviated from the design specifications, failed to properly affix warnings or instructions and (was) defectively designed and manufactured".The device is no longer 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.

Manufacturer Narrative

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 physician did not receive data showing a four second variance in patient's heartbeat until four days after the data was recorded.It was alleged by an attorney that during the four day time frame the patient experienced a second variance in their heartbeat which caused the icm patient to lose consciousness, fall and suffer serious bodily injuries including a fractured skull which allegedly caused a massive seizure which led to the patient's death.

• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 7738740
• MDR Text Key: 115673424
• Report Number: 9614453-2018-02707
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00643169476998
• UDI-Public: 00643169476998
• 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: other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/14/2017
• Device Model Number: LNQ11
• Device Catalogue Number: LNQ11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/24/2019
• Date Device Manufactured: 03/21/2016
• 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): Death; Other
• Patient Age: 54 YR