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); High impedance (1291); Low impedance (2285)

Patient Problem Inadequate Pain Relief (2388)

Event Date 06/10/2022

Event Type  malfunction  

Manufacturer Narrative

This regulatory report is being submitted as part of a retrospective review as part of remediation plan 411.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a friend/family member regarding a patient who was implanted with an implantable neurostimulator (ins) for low ef, no history vt/vf (scd-heft) and spinal pain indications.The reason for call was caller reported pt was not feeling their stimulation and this issue began today.Caller notified a rep of the issue and caller left a voicemail.During the call ps walked caller through adjusting the program settings on the mystim pc app on the handset.Caller confirmed that therapy was on and after caller adjusted the pt's stimulation settings by increasing the stimulation the pt didn't feel any stimulation or relief.Caller noted pt did not have any recent falls or traumas and there were no visible damages to the handset or communicator.The issue was not resolved.The patient was redirected to their healthcare provider to further address the issue.Caller noted they haven't seen the pt's hcp since implant and for stitches.Ps advised caller to contact pt's hcp to connect with a representative to get the pt's implant checked and be seen for adjustment/reprogramming.Redirected caller: patient's hcp additional information was received from the manufacturer representative (rep).It was reported that there were high impedances.Connection check shows red x 0,1,2,3,1.Impedance check shows red x >40000 0,1,2,11.Impedance check shows possible open short at 3- 39505, 8<(>&<)>9 40000 ,10- 33982.Patient reported unable to feel stimulation.Reprogrammed patient using electrodes eight 910.Patient states able to feel stimulation over painful areas.The issue was resolved.

• 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: 18730838
• MDR Text Key: 336733032
• Report Number: 3004209178-2024-05086
• Device Sequence Number: 1
• Product Code: LGW
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/19/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2023
• Device Model Number: 977006
• Device Catalogue Number: 977006
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/15/2022
• Initial Date FDA Received: 02/19/2024
• Date Device Manufactured: 10/04/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Male