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

Model Number 37612

Device Problems Migration or Expulsion of Device (1395); Device Difficult to Program or Calibrate (1496); Insufficient Information (3190)

Patient Problems Headache (1880); Visual Impairment (2138); Dizziness (2194); Neck Stiffness (2434); Insufficient Information (4580)

Event Date 12/01/2020

Event Type  Injury  

Event Description

Information was received from a patient (pt) regarding an implantable neurostimulator (ins).The reason for call was pt said they had one of the wires going to their brain redone, 2 weeks ago, because the wires in their brain were not in the right place, one lead was 2 millimeters off and the other one was not that far off.Patient reported their initial implant procedure was done while they were asleep and when they woke up from anesthesia they noticed certain things were kind of off, their vision was off, they were dizzy, they had chronic headaches, a month or so later they noticed their transmitting wire was too tight in their neck and their battery slipped it was pulling down and up at the same time causing more headache and all the other things.Pt said they were not able to be programmed, they are currently at the lowest number, one side is 1.2, the other side is 1.8, they've been at those settings for over a year and had to increase their medication to every 2.5 hours.Pt said it took them 9 months to get answers and relief they had a redo of the extension wires on (b)(6) 2021.Pt said they had a second opinion, and they did mris and all these things and they realized the leads were not optimal in place.On august 3rd they had one of the wires going into their brain redone, they took out one lead and placed new.Pt said it is not hooked up yet, it will be connected with a new device in october.In september they will have the other lead replaced and will get the newest dbs system.The patient was redirected to their healthcare provider to further address the issue.

Manufacturer Narrative

B3: date is approximate.Month and year are confirmed valid.Section d references the main component of the system.Other medical products in use during the event include: brand name activa; product id 3708660 (serial: (b)(6), product type: 0191-extension; implant date (b)(6) 2020; explant date (b)(6) 2021, brand name activa; product id 3708660 (serial: (b)(6),product type: 0191-extension; implant date (b)(6) 2021; explant date brand name activa; product id 3387s-40 (lot: va275sc); product type: 0200-lead; implant date (b)(6) 2020; explant date brand name activa; product id 3708660 (serial: (b)(6); product type: 0191-extension; implant date (b)(6) 2021; explant date brand name activa; product id 3708660 (serial: (b)(6); product type: 0191-extension; implant date (b)(6) 2020; explant date (b)(6) 2021 brand name activa; product id 3387s-40 (lot: va27x8h); product type: 0200-lead; implant date (b)(6) 2020; explant date.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 consumer reported they were in the process of having their leads and battery replaced.The consumer also mentioned their charger needed to be replaced.

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: 17627499
• MDR Text Key: 322022096
• Report Number: 3004209178-2023-14943
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000100360
• UDI-Public: 00763000100360
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2021
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/25/2023
• Date Device Manufactured: 07/31/2020
• 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 Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 64 KG