MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number 37612

Device Problems Failure to Interrogate (1332); Improper or Incorrect Procedure or Method (2017); Battery Problem (2885); Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/29/2023

Event Type  malfunction  

Manufacturer Narrative

B3: date is approximate.Year is confirmed valid.Refer to manufacturer's report 3004209178-2024-00418 for details pertaining to the reportable related event.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

It was reported that the patient states his batteries have gone down and he needs help charging the implant.Patient services (pss) asked patient to start a charging session.Patient states he is seeing the 8 coupling boxes but the coupling boxes are not filling in.The caller reported to having poor coupling.The caller confirmed that the implantable neurostimulator (ins) was on via the 37751 recharging screen.The issue was not resolved through troubleshooting.An email was sent to repair to replace the recharger antenna.No symptoms were reported.Additional information was received from the patient stating they have 2 implants, one is located in their chest and the other is in their abdomen.The caller described to seeing the reposition antenna screen when attempting to connect to the implantable neurostimulator (ins) in their stomach.When the caller attempted to connect to the ins in their chest, they reported to seeing poor coupling.The caller stated that they have had this issue with both 37751 rechargers.Pss reviewed that 1 recharger antenna replacement was already previously requested.Pss said that if the issue persists to follow-up with the healthcare provider (hcp).  additional information was received from the patient stating they installed the replacement recharger antennas they received, but they have been seeing the reposition antenna screen on each recharger when they attempt to charge their inss.During the call, the patient attempted to charge their inss with each recharger, but every attempt resulted in them seeing the "reposition antenna" screen.The patient confirmed the recharger antenna was in the proper position.Agent asked the patient for the date they were last able to successfully charge their inss, and they said it was about 2 months ago.Based on that information, agent reviewed that the ins batteries could potentially be overdischarged given that neither recharger would connect to either of their inss.The patient did not have their 37642 patient programmer with them, so agent was unable to determine if the patient programmer could communicate with the inss.The patient was redirected to their hcp to further address the issue.The patient stated that they have an appointment on (b)(6) 2024 with a manufacturing representative (rep).Agent advised the patient to bring their recharging equipment with them for that appointment.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18469450
• MDR Text Key: 332980901
• Report Number: 2182207-2024-00102
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169529762
• UDI-Public: 00643169529762
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2016
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/28/2023
• Date Device Manufactured: 08/31/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Male