MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. VERSA IPG; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	VEDR01
Medical Device Problem Code	Failure to Interrogate (1332)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2026
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that a patient with a implantable pulse generator (ipg) experienced no telemetry with the mycarelink monitor while trying to send a transmission, and the transmission progress indicator became stuck at 25% without advancing.The issue was described as a reader position problem.Troubleshooting was performed by power cycling the monitor, moving the reader, and using a dry washcloth, but the issue was not resolved.The ipg remains in use.The patient was referred to the clinic.No patient complications have been reported as a result of this event.

• Brand Name: VERSA IPG
• Common Device Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• 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: 25147499
• Report Number: 3004209178-2026-08093
• Device Sequence Number: 10745101
• Product Code: NVZ
• UDI-Device Identifier: 00613994222114
• UDI-Public: (01)00613994222114(17)160828
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: P980035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/12/2026

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: 08/28/2016
• Device Model Number: VEDR01
• Device Catalogue Number: VEDR01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 05/12/2026
• Date Device Manufactured: 03/04/2015
• 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: 407658 LEAD, 407645 LEAD
• Patient Age: 77 YR
• Patient Sex: Male