MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. VANTA; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number 977006

Device Problems Failure to Deliver Energy (1211); Energy Output Problem (1431); Application Program Problem (2880); Patient Device Interaction Problem (4001)

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 04/24/2022

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins).The patient reported that they "took a bad trip" on (b)(6) 2022, and since the "trip", the pt said their therapy had not been working quite right.Pt said their knee gave out and they ran unbalanced for 20 feet and used their arms to stop them at a wall.Pt then got code "system error: 0x164fb9f6: system encountered an unexpected error" and the pt could not feel their therapy even though they turned their therapy up to 7.2.During the call, the pt confirmed their therapy was turned on and adjusted their therapy from 5.2 to 8.5.Pt could feel their therapy at 8.5 and, when the pt crossed their legs, the therapy got very strong.Pt turned their therapy down to 5.2 and mentioned they could still feel their therapy.Pt did not have adaptive stim active on their handset group a.Pt said their handset asks them to reconnect when the screen went off.Patient services specialist explained handset function and expectations to the pt.The patient was redirected to their healthcare provider to further address the issue.Pt said they would be going to their hcp to try a new program on (b)(6) 2022.

• Brand Name: VANTA
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14242706
• MDR Text Key: 290464580
• Report Number: 3004209178-2022-05414
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00763000411923
• UDI-Public: 00763000411923
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2023
• Device Model Number: 977006
• Device Catalogue Number: 977006
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/27/2022
• Date Device Manufactured: 12/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Male