MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO PROTECTA XT VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	D314VRG
Medical Device Problem Codes	Failure to Charge (1085); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2023
Type of Reportable Event	Malfunction
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 patient received inappropriate shocks due to a suspected low voltage fracture of the right ventricular (rv) lead.It was noted that the lead integrity alert (lia) was triggered due to high rate non-sustained episodes and elevated sensing integrity counter (sic).Several alerts were triggered for lead noise and high/undefined pacing impedance.The patient was hospitalized and the icd function was turned off as it was noted the patient is currently in hospice.The system remains in-situ currently as the physician is determining next steps due to patient's pre-existing conditions.No further patient complications have been reported as a result of this event.It was further reported that the rv lead exhibited a variation in pacing impedance measurements, and oversensing.In addition, the device reached end of service (eos), and a charge circuit timeout occurred.The charge circuit was inactive, and the patient refused to have the implantable cardioverter defibrillator (icd) replaced.

• Brand Name: PROTECTA XT VR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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 ; 7635269277
• MDR Report Key: 19610026
• Report Number: 3004209178-2024-13538
• Device Sequence Number: 15475032
• Product Code: LWS
• UDI-Device Identifier: 00613994677877
• UDI-Public: 00613994677877
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2023
• 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): 06/25/2024

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: 04/14/2013
• Device Model Number: D314VRG
• Device Catalogue Number: D314VRG
• 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: 05/31/2024
• Initial Report FDA Received Date: 06/25/2024
• Date Device Manufactured: 10/14/2011
• 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: 693565 LEAD
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 68 KG