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

Model Number 37602

Device Problems Failure to Deliver Energy (1211); Communication or Transmission Problem (2896); Electromagnetic Compatibility Problem (2927)

Patient Problems Muscular Rigidity (1968); Visual Disturbances (2140); Insufficient Information (4580)

Event Date 04/05/2023

Event Type  malfunction  

Event Description

It was reported that, maybe 2 months ago, the patient's left implantable neurostimulator (ins) turned off and they did not know why.The caller confirmed they were able to turn the left ins back on at that time.Today, the caller stated that the left ins turned off again and they didn't know why.The caller mentioned that the patient lives in a memory care facility and thought perhaps someone with a magnet got too close to the left ins.The caller stated that the patient's nurse was unable to turn the left ins back on.Agent called the patient's aid, asked to speak with the patient's nurse, and the nurse then stated that today they noticed the patient's right eye was closed, their right hand was short of shriveled, and their right arm was drawn up.The patient representative stated that those symptoms occur when the left ins is turned off, and mentioned that the patient has no use of their right side when that happens.The nurse initially saw the 'poor communication' screen when they checked both the left and right inss.The nurse confirmed they had the programmer positioned over the inss properly.The nurse also saw the 'patient programmer batteries are low' information screen, so agent had the nurse put in brand-new aaa batteries.After putting in new aaa batteries, the nurse confirmed the patient programmer synchronized with the right ins.For the right ins, therapy was on and the ins battery was ok.When the nurse tried to synchronize the programmer with the left ins, they continued to see poor communication.Agent reviewed that the programmer was working correctly and advised the caller to have the patient follow up with their managing healthcare provider (hcp) to further address the issue.

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.

Event Description

Additional information received from the manufacturer¿s representative (rep) reported the patient¿s wife called them to ask for how to check the battery using the remote so they could show the staff at the nursing home.The patient¿s spouse mentioned they thought the staff may have inadvertently turned off one of the generators while trying to use the remote, so they wanted to make sure it was turned back and give staff an in-service on the device.The patient¿s spouse mentioned they thought a rep was scheduled to speak with the staff on device use.

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: 17098767
• MDR Text Key: 317751060
• Report Number: 3004209178-2023-10175
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000519223
• UDI-Public: 00763000519223
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2023
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/13/2023
• Date Device Manufactured: 05/09/2022
• 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: 81 YR
• Patient Sex: Male