MCS Supplemental Warranty

Supplemental Warranty	Warranty Summary	Expires
HVAD System: Power Switching	Where HVAD power source(s) has experienced unexpected power switching behavior and unexpected audible tones, Medtronic will initially provide power source replacement(s), without charge, to the warranty holder. If the unexpected behavior persists, after replacement of the HVAD power source(s), Medtronic will provide an HVAD Controller, without charge, to the warranty holder.	December 15, 2024
HVAD: Failure to Restart Controller Exchange	Where patients with an affected device in the failure to restart subset have a primary controller beyond two (2) years of service and the physician has made the medical judgment that prophylactic exchange of the primary controller is in the individual patient’s best interests, the warranty holder is eligible for: a replacement of (2) controllers (i.e., one “primary” and one “backup” controller) per patient with an Affected Device, at no charge.	December 15, 2024
HVAD: Failure to Restart Non-Prophylactic Pump Exchange	For Non-Prophylactic exchange due to any device failure to restart at any time in patients with an affected device from the December 2020 and August 2023 Product Advisory: Replacement Device System. Warranty holders are eligible for a warranty credit in the amount of the cost of an HVAD System. If an insurance claim is denied, warranty holders are also eligible for 150% of the hospital specific DRG payment. Patient Support. Patients are eligible to apply for up to $10,000 in URM expenses associated with the patient’s portion of costs of the HVAD System exchange procedure to a competitive device (inclusive of any co-pays, coinsurance or deductibles paid or owed by patients, travel expenses).	December 15, 2024
HVAD: Failure to Restart Prophylactic Pump Exchange	For Prophylactic exchanges of an HVAD Pump serial number that is in the subset of “Affected Devices” from the December 2020 and August 2023 Product Advisory where the physician has made the medical judgment that the prophylactic exchange, although not recommended by Medtronic, is in the individual patient’s best interests: Replacement Device System. Warranty holders are eligible for a warranty credit in the amount of the cost of an HVAD System. If an insurance claim is denied, warranty holders are also eligible for 150% of the hospital specific DRG payment. Patient Support. Patients are eligible to apply for up to $10,000 in URM expenses associated with the patient’s portion of costs of the HVAD System exchange procedure to a competitive device (inclusive of any co-pays, coinsurance or deductibles paid or owed by patients, travel expenses).	December 15, 2024
HVAD: Prophylactic Pump Exchange for Non-Recalled Devices	For Prophylactic exchanges of an HVAD Pump serial number that is outside of the subset of “Affected Devices” from the December 2020 Product Advisory where the physician has made the medical judgment that the prophylactic exchange, although not recommended by Medtronic, is in the individual patient’s best interests: Patient Support. Patients are eligible to apply for up to $10,000 in URM expenses associated with the patient’s portion of costs of the HVAD System exchange procedure to a competitive device (inclusive of any co-pays, coinsurance or deductibles paid or owed by patients, travel expenses).	December 15, 2024
HVAD: Pump Weld Non-Prophylactic Exchanges	Replacement System: Warranty holders are eligible for a warranty credit in the amount of the cost of an HVAD System. If an insurance claim is denied, warranty holders are also eligible for 150% of the hospital specific DRG payment. Patient Support: Patients are eligible to apply for up to $10,000 in Unreimbursed Medical (URM) expenses associated with the patient’s portion of costs of the HVAD System exchange procedure to a competitive device (inclusive of any co-pays, coinsurance or deductibles paid or owed by patients, travel expenses).	December 15, 2024
HVAD: Pump Weld Non-Prophylactic Pump Removal	For Non-Prophylactic removal which results in a transplant: Patient Support: Patients are eligible to apply for up to $10,000 in Unreimbursed Medical (URM) expenses associated with the patient’s portion of costs of the HVAD System exchange procedure to a competitive device (inclusive of any co-pays, coinsurance or deductibles paid or owed by patients, travel expenses).	December 15, 2024
HVAD: Pump Weld Prophylactic Exchanges	Where the physician has made the medical judegment that the prophylactic exchange, although not recommended by Medtronic, is in the individual patient's best interests: Patient Support: Patients are eligible to apply for up to $10,000 in Unreimbursed Medical (URM) expenses associated with the patient’s portion of costs of the HVAD System exchange procedure to a competitive device (inclusive of any co-pays, coinsurance or deductibles paid or owed by patients, travel expenses).	December 15, 2024
HVAD: Battery Performance Update	This Supplemental Limited Warranty relates to the May 31, 2023, Medtronic HeartWare™ Ventricular Assist Device (HVAD™) System Battery Performance Update communication. Medtronic is communicating a manufacturing change to the HeartWare HVAD System batteries. Specifically, the manufacturing change is intended to lessen the occurrence of potential battery electrical fault issues. This Supplemental Limited Warranty applies to the replacement of all patient’s used batteries and hospital owned loaner batteries. Patient Support: Patients are eligible to apply for up to $2000 in Unreimbursed Medical (URM) expenses related to travel, outside of a normal clinic visit, to their VAD center for the exchange of product outlined in the FCA (inclusive of any co-pays, coinsurance or deductibles paid or owed by patients and/or travel expenses). Receipts for all potentially reimbursable expenses are required.	February 29, 2024