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

Model Number 37603

Device Problems Electromagnetic Interference (1194); Patient Device Interaction Problem (4001)

Patient Problems Dyspnea (1816); Pain (1994); Anxiety (2328); Shaking/Tremors (2515); Sleep Dysfunction (2517)

Event Date 01/21/2024

Event Type  malfunction  

Event Description

It was reported that the patient accidentally walked through a metal detector to get back into the hotel they were staying at in mexico, and since then the patient had severe anxiety, could not sleep, their hands were shaking, and they had a lot of difficulty breathing.The patient added that they had a lot more pain than usual when walking.The caller does not think the patient fell prior to this event, but they thought the patient's swinging motion while they were golfing might have "dislodged something." the caller mentioned that the patient was on too many medications between their parkinson's and anti-anxiety medications.Caller did not bring the programmer with them, so implant status could not be determined.Caller mentioned the patient slept better last night, and at the time of the call they were calm and not shaking.Despite the patient feeling better, the caller requested to have someone check the p patient's implant to ensure it was working correctly and not overstimulating the patient.The caller stated that the patient was on vacation in mexico at the time of the call, and that they would be in mexico for another 2-3 weeks.Agent redirected the caller to the patient's healthcare provider.

Manufacturer Narrative

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: 18571398
• MDR Text Key: 333608496
• Report Number: 3004209178-2024-01915
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000100353
• UDI-Public: 00763000100353
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2021
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/23/2024
• Date Device Manufactured: 05/08/2020
• 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: 81 YR
• Patient Sex: Male