MAUDE Adverse Event Report: MEDTRONIC INC. CLARIA MRI QUAD CRT-D SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTMA 1QQ

Device Problems Nonstandard Device (1420); Failure to Transmit Record (1521); Failure to Analyze Signal (1539); Battery Problem (2885); Therapeutic or Diagnostic Output Failure (3023); No Pacing (3268); Noise, Audible (3273)

Patient Problems Nausea (1970); Tachycardia (2095)

Event Date 07/04/2019

Event Type  Death  

Event Description

Three days of v-tac device; mr.(b)(6) felt sick and nauseous, (b)(6) 2019 while on vacation.Returned home and proceeded directly to (b)(6).Was admitted to (b)(6) for evaluation and was in v-tac.Electrophysiology was called to analyze his medtronic claria icd device, dtma 1qq, serial number: (b)(4).Findings, mr.(b)(6) was in v-tac for three consecutive days according to his device analysis, his device failed to pace his heart into a normal rhythm and (b)(6) tried to re-set his heart rhythm by using his device.After numerous tries, it did work to slow his heart rate for a short period of time but all this maneuvering put undue stress on his heart.During mr.(b)(6) first hospital stay, his medicines were evaluated for changes to try to help his stressed heart.Mr.(b)(6) continued to have problems even after his first discharge from (b)(6).Mr.(b)(6) second admission to (b)(6) for in (b)(6) was for the same problem.His heart medications were adjusted but due to the stress of the three days of continual v-tac his heart was already damaged.In order to try to get mr.(b)(6) heart rhythm stable, ablation was discussed.Mr.(b)(6) had an ablation and his medicines were used to keep his heart as regular as possible after the damaged created by the icd device not preforming as it was designed.Mr.(b)(6) had a third admission to (b)(6) for medication adjustments to control his creatinine levels.In (b)(6) of 2020 mr.(b)(6) icd evaluation and analysis failed to transmit during his report date to (b)(6).Mr.(b)(6) wife called to ask if the report when through.It had not, so it was sent once again.This wasn't the first time his icd failed to analyze.In (b)(6) of 2020 mr.(b)(6) had an incident with his icd making a high pitch siren sound.Mr.And mrs.(b)(6) were never told his icd would ever make any sounds and they were very scarred.They called (b)(6) and told them about the loud siren sound.The person on the phone laughed and said, oh come on in, we can turn that off.Mr.And mrs.(b)(6) asked why the (b)(6) weren't more concerned with this type of noise, it obviously meant something severe was happening to the device.No explanation was given.We learned from the medtronic website that mr.(b)(6) device is on the recall list for depleted battery.Mr.And mrs.(b)(6) found out that his battery was defective.Mr.(b)(6) passed away on (b)(6) 2020 from the damaged caused to his heart from his icd non-pacing him out of v-tac for three days in (b)(6) 2019.This medtronic device was the patients fourth device (implanted in upper left shoulder) four device in 28 years.Patient had no problems with former three icd's implanted in abdomen area.Fda safety report id# (b)(4).

• Brand Name: CLARIA MRI QUAD CRT-D SURESCAN
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC INC.
• MDR Report Key: 11900465
• MDR Text Key: 253476309
• Report Number: MW5101588
• Device Sequence Number: 1
• Product Code: NIK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DTMA 1QQ
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/27/2021
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 86