MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. AMPLIA MRI QUAD CRT-D SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number	DTMB1QQ
Medical Device Problem Codes	Failure to Deliver Shock/Stimulation (1133); Device Sensing Problem (2917)
Health Effect - Clinical Code	Ventricular Fibrillation (2130)
Date of Event	09/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that the right ventricular (rv) lead had a lead integrity alert (lia) triggered due to high-rate non-sustained episodes and short v-v intervals.It was noted that the rv lead exhibited undersensing and oversensing.It was also noted that the rv lead had an impedance warning due to low impedance measurements.There appears to be undersensing of ongoing ventricular fibrillation (vf) along with possible chest compressions and external shock shown on the electrograms (egm).It was further reported that the cardiac resynchronization therapy defibrillator (crt-d) inappropriately withheld therapy due to the device supra ventricular tachycardia (svt) discriminator feature that can help prevent the inappropriate detection of atrial fibrillation (af) with rapid ventricular response as a ventricular tachycardia (vt) by evaluating the stability of ventricular intervals.It was noted that the device classified the episode as svt, but it was suspected to be true ventricular fibrillation (vf) resulting in a delay in therapy.It was also noted that the healthcare professional felt the patient was not shocked appropriately.Eventually chest compressions and external shocks was needed and shown on the electrograms (egm).The device and lead remain in use.No further patient complications have been reported as a result of this event.

• Brand Name: AMPLIA MRI QUAD CRT-D SURESCAN
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 7635269277
• MDR Report Key: 20487298
• Report Number: 3004209178-2024-20609
• Device Sequence Number: 4096276
• Product Code: NIK
• UDI-Device Identifier: 00643169543386
• UDI-Public: 00643169543386
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P010031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/28/2017
• Device Model Number: DTMB1QQ
• Device Catalogue Number: DTMB1QQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 10/18/2024
• Date Device Manufactured: 11/02/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 459888 LEAD, 5076-58 LEAD, 6935M72 LEAD.
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 75 KG