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

Model Number 37612

Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Emotional Changes (1831); Erythema (1840); Memory Loss/Impairment (1958); Pain (1994); Scar Tissue (2060); Shaking/Tremors (2515); Ambulation Difficulties (2544); Cognitive Changes (2551); Tissue Breakdown (2681); Device Embedded In Tissue or Plaque (3165)

Event Date 05/27/2022

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id 3389s-40 lot# serial# (b)(6) implanted: (b)(6)2018 explanted: (b)(6)2022 product type lead product id 3389s-40 lot# serial# (b)(6) implanted: (b)(6)2018 explanted: (b)(6)2022 product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 3389s-40, serial/lot #: (b)(6), product id: 3389s-40, serial/lot #: (b)(6), 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

The reason for the call was the patient was wanting statics on how often implantable neurostimulator (ins) are removed.Patient services (pss) reviewed the patient that pss do not have access to that data.The patient stated that she is still trembling and the medication she is currently on is not helping with her symptoms.The patient stated an healthcare provider (hcp) at medstar in washington dc told her that the wires (leads) in the thalamus are not placed in the right place.The patient stated that her et gets worse when she gets emotional.The patient stated that even with the dbs she was having trouble walking and was falling.The patient stated that her therapist thinks the stimulator caused memory and cognitive problems.The patient stated that she is seeing a plastic surgeon tomorrow to get the scar tissue removed.Pss redirected to neurologist to follow-up regarding the leads and extension still being implanted.The caller stated the hcp snipped the wire (extension) where the ins was but is unable to get a new ins connected due to how the wire was cut.The patient stated that she thinks the wire is still in there, because how much it hurts depends on how she moves.The caller stated she thinks the wire is "still dangling in the scar tissue".The patient stated that only the ins was removed not the leads and the extension.The patient stated that they currently have an angry swollen painful scar since having the ins explanted in october of 2022.The patient stated that they did inform the neurologist about the scar who referred her to the primary care physician.The primary care physician then prescribed a topical cream for the scar.The patient stated that its red and sore underneath, it hurts, and she can't wear a bra.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
• 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: 17371464
• MDR Text Key: 319742722
• Report Number: 3004209178-2023-13064
• Device Sequence Number: 1
• Product Code: PJS
• UDI-Device Identifier: 00643169529762
• UDI-Public: 00643169529762
• 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
• Report Date: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2018
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2023
• Date Device Manufactured: 01/11/2018
• 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: 75 YR
• Patient Sex: Female