MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M

Model Number	37602
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Impedance Problem (2950); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Brain Injury (2219); Discomfort (2330); Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)
Date of Event	11/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10.Section d information references the main component of the system.Other relevant device(s) are: product id: 3387-40, serial/lot #: (b)(6), ubd: 11-mar-2009, udi#: (b)(4) ; product id: 748251, serial/lot #: (b)(6), ubd: 18-mar-2009, udi#: (b)(4); product id: 748251, serial/lot #: (b)(6), ubd: 18-mar-2009, udi#: (b)(4).Please note that this is also a correctional report.All information has been reported in manufacturer report #3004209178-2022-15693 for the bilateral ins.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that the healthcare provider (hcp) scheduled a removal of dbs system for the patient, due to system not being used for past 6 years for dystonia that was never resolved.During the procedure, the hcp described bony ingrowth over the burr hole device and difficulty removing the initial lead.After some time, the lead was removed and hcp described only seeing 3 electrodes present on the removed lead.He then left the operating room to speak with the patients husband and express his concerns about attempting to remove the second lead.The hcp had difficultly removing lead due to tissue ingrowth, upon removing lead, last electrode appeared to have been stripped from lead and remained in the brain.The husband detailed that his wife¿s main discomfort was with the implantable neurostimulators (ins) and extensions and to just remove those.Hcp proceeded to remove the patients bilateral ins and extensions.Hcp also stated that the patient expressed concerns in 2016 regarding impedances on a contact, as described by her managing ph ysician and wondered if they had contributed to headaches at that time.Additional information was received: it was reported that the date of removal was on (b)(6) 2022 and stated the sheath of the electrode was disintegrated and stated there was no casing on the wire and caused the ingrowth.They also mentioned that electrode 0 was stated that the impedance issue and massive headaches back in 2014-2015 and programmed around broken off.The physician said the rest of the device was still implanted because it was too dangerous to remove.Additional information was received reporting that the surgeon was unable to remove the leads and the wires fell apart upon attempted removal.The leads were the same and the battery was changed once.They are now completely mri incompatible.In addition, the patient had undergone 18 months of rehab due to a brain injury (tbi) from the device.Additional information was received reporting that the right lead that fell apart remained lodged in their frontal lobe, more pieces embedded throughout their skull, and half of a left lead that remained in (b)(6).

• Brand Name: ACTIVA
• Common Device Name: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M
• 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: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20651672
• Report Number: 3004209178-2024-21761
• Device Sequence Number: 12823962
• Product Code: MRU
• UDI-Device Identifier: 00613994761057
• UDI-Public: 00613994761057
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: H020007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/11/2024

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: 07/14/2017
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 11/11/2024
• Date Device Manufactured: 01/23/2016
• 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 H11...."
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female