MAUDE Adverse Event Report: MEDTRONIC CARDIAC RHYTHM MGMT/MEDTRONIC, INC. MEDTRONIC IMPLANTABLE LOOP RECORDER; RECORDER, EVENT, IMPLANTABLE CARDIAC

Model Number LNQ11

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Pain (1994); Burning Sensation (2146)

Event Date 01/07/2020

Event Type  Injury  

Event Description

Pt¿s implanted loop recorded heated up during a 3d brain mr with these parameters: this was a 3d brain protocol with the following scans and sar (remember normal mode is 2.0 w/kg); localizer (0.02w/kg).Tra t1 sheath (0.15 w/kg) 3d flair-md-p (0.15 w/kg) tra perfusion straight (0.10 w/kg) swi_images.(0.02 w/kg) tra_t2tse stealth (0.60 w/kg) tra sti straight (0.32 w/kg) tra t1 stealth (0.15 w/kg) sag t1fs tse.(0.65 w/kg) cor t1fs 0.65 w/kg) a 20 channel head coil was used.Pt c/o pain and burning to technologist post scan.A radiologist assessed patient and documented as follows: transient heating of the subcutaneous tissues at the site of the patient¿s loop recorder.No evidence of cardiac dysfunction on physical examination.Symptoms were subsiding prior to discharge.The patient was instructed to return to the ed if he developed worsening burning at the loop recorder site or shortness of breath, light headiness, or chest pain.On follow up phone call 2 days later pt continued to complain of pain and reported he feels like he has the ¿worst sunburn of his life¿.Skin over chest is erythematous, but no blistering.Phoned pcp to notify to continue to follow up with patient.Fda safety report id # (b)(4).

• Brand Name: MEDTRONIC IMPLANTABLE LOOP RECORDER
• Type of Device: RECORDER, EVENT, IMPLANTABLE CARDIAC
• Manufacturer (Section D): MEDTRONIC CARDIAC RHYTHM MGMT/MEDTRONIC, INC.
• MDR Report Key: 9632178
• MDR Text Key: 176750753
• Report Number: MW5092503
• Device Sequence Number: 1
• Product Code: MXC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: LNQ11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 34 YR