MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number	37601
Medical Device Problem Codes	Failure to Power Up (1476); Battery Problem (2885)
Health Effect - Clinical Codes	Stroke/CVA (1770); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2012
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id 37642 lot# serial (b)(6).Product type programmer, patient section d information references the main component of the system.Other relevant device(s) are: product id: 37642, serial (b)(6) , ubd: , udi#: (b)(4).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 or Problem Description
It was reported that their speech was affected when the implantable neurostimulator (ins) was turned on.The patient said their speech was not affected when the ins was turned off.The patient mentioned that they felt like they had to choose between their movement disorder and their speech, so they chose to have the movement disorder and normal speech.Then, the patient stated that their ins battery was "out of juice," but they never got it replaced because of how it affected their speech whenever the ins was turned on.Agent was unable to confirm that the patient's ins reached eos because the patient did not have their patient programmer with them, but the patient stated that they did see a screen on the patient programmer that indicated the ins had reached eos.The patient's reason for calling was because they had a stroke this past month and their healthcare provider (hcp) wants to do an mri.The patient mentioned that they spoke with patient services earlier today about mri compatibility and were redirected to their managing hcp for assistance.The patient stated that they called their managing hcp, but the hcp told the patient that they only keep their records for 7 years, and redirected the patient to the manufacturer for further assistance.Agent reviewed mri compatibility information and redirected the patient back to their hcp.Additional information was received from the patient stating the patient called previously, they were under the impression their implantable neurostimulator (ins) battery had reached eos, but this could not be confirmed because they did not have their patient programmer with them.During the call, the patient programmer would not power on (the patient mentioned the batteries were corroded).The patient put brand-new batteries in the programmer, but it still would not power on.As the patient was replacing the batteries, they mentioned they had "such shaky hands." agent did not ask further info regarding the shaky hands because the patient had indicated in the previous phone call that they always kept the ins turned off.The patient was redirected to their hcp should they find that their ins is in fact in the eos state.Agent reviewed that mri eligibility cannot be determined if the ins is in the eos state.The patient mentioned that they are seeing their neurologist today; agent reviewed that the neurologist could also check the ins to determine if it has reached eos.

• Brand Name: ACTIVA
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 18628994
• Report Number: 3004209178-2024-03272
• Device Sequence Number: 7725460
• Product Code: MHY
• UDI-Device Identifier: 00613994934604
• UDI-Public: 00613994934604
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/02/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/14/2014
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 02/02/2024
• Date Device Manufactured: 07/18/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H10...."
• Patient Age: 55 YR
• Patient Sex: Female