MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number 37612

Device Problems Communication or Transmission Problem (2896); Positioning Problem (3009); Patient Device Interaction Problem (4001)

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

Event Date 01/10/2024

Event Type  malfunction  

Event Description

Information was received from a patient regarding a recharger.The patient reported difficulty charging the implanted neurostimulator.Patient services (pss) had the caller reset the wireless recharger (wr) off the docking station and attempt to connect to the ins.The caller confirmed that the wr connected and maintained a connection to the ins.The troubleshooting steps that were taken resolved the issue.The caller stated that they lost their drape.Pss sent an email to repair to replace the drape.The patient called back to report that they continued to have difficulty charging their implant.The patient stated that the wr will disconnect from their implant immediately unless they take it out of the drape and hold the wr against the implant without moving.The patient noted that the wr will lose the connection from their implant if they move slightly.The patient mentioned that they reset the wr, but the connectivity issue persisted.The wr was not dropped and did not get wet prior to this issue.Agent asked the patient if they had any falls/trauma prior to this issue, and the patient confirmed that they took a fall but that happened about 3 months ago.The patient did not indicate that the fall was related to the device/therapy.Agent re-opened the case and assigned to self to send an email to repair to replace the wr.The patient was advised to have their implant checked by their hcp if the replacement wr does not resolve the connectivity issue.No symptoms were reported.Additional information received from the manufacturer¿s representative (rep) reported the recharger would connect, but it wouldn¿t maintain the connection to the implant with either of the rechargers they used.The patient reported they had some traumatic even that may have affected the position of the implant, but there were no specific details at this time.The rep was going to try and have someone meet with the patient.

Manufacturer Narrative

Section d references: product id wr9200, serial# unknown, product type recharger.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.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• 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: 18638632
• MDR Text Key: 334882884
• Report Number: 3004209178-2024-03465
• Device Sequence Number: 1
• Product Code: MHY
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2023
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2024
• Date Device Manufactured: 06/08/2022
• 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
• Treatment: SEE H10
• Patient Age: 62 YR
• Patient Sex: Male