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

Model Number	D334VRG
Medical Device Problem Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Codes	Shock from Patient Lead(s) (3162); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: event date is not known.Please see b5 for approximate date range, if applicable.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 by the patient that the implantable cardioverter defibrillator (icd) delivered an inappropriate shock due to their low sodium count.The icd was explanted and replaced. no further patient complications have been reported as a result of this event.

• Brand Name: PROTECTA VR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): MEDTRONIC PUERTO RICO JUNCOS; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO JUNCOS; 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: 25225615
• Report Number: 3004209178-2026-08605
• Device Sequence Number: 13210917
• Product Code: LWS
• UDI-Device Identifier: 00613994677846
• UDI-Public: (01)00613994677846(17)130828
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/19/2026

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/28/2013
• Device Model Number: D334VRG
• Device Catalogue Number: D334VRG
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 05/19/2026
• Date Device Manufactured: 03/10/2012
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 693558 LEAD.
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male