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

Model Number 37612

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intracranial Hemorrhage (1891); Dysphasia (2195)

Event Date 11/01/2022

Event Type  Injury  

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

It was reported that the patient's (pt's) therapy was turned on (b)(6) 2022 and everything worked well until a little less than 3 weeks ago.The pt's speech got a little thick and then all of a sudden the symptoms were like aphasia, not like the speech was slurred or anything but like the pt wanted to say something and it wouldn't come out.Pt said they've had a few occurrences of this.Pt's neurologist tends to think this was not related to the deep brain stimulation (dbs).The circumstances that led to the reported issue were asked but unknown.Pt said they could see how dbs could effect speech or gait because the healthcare provider (hcp) gave pt a range with settings and when settings are turned up, which pt said settings were turned up currently, their speech was a little bit labored but hardly noticeable.Pt said however these episodes were like all of a sudden their speech shut down and pt would try to talk and it just wasn't working.Hcp has pt scheduled for an magnetic resonance imaging (mri) to make sure pt doesn't have a transient ischemic attack.Pt said they met with manufacturer representative (rep) on friday and rep said they would try a new program and set up a second group b because the pt couldn't get into see the neurologist.Rep changed the polarity on the probes and pt had another incident the day after programming on sat and the rep told the pt they needed to see their neurologist.The issue was not resolved.The patient was redirected to their healthcare provider to further address the issue.Pt said they saw hcp today and hcp was trying to get that mri set up and said that he would touch base with rep.Additional information received from the consumer reported they had their symptoms and were told go the emergency room.The consumer stated they had an mri where they found a subdural hematoma.A neurosurgeon was called who stated they didn¿t think it was related to the dbs, instead of drilling the burr holes, they elected to turn it over to the endovascular surgeon who did a catheter and they plugged up the rupture which would eventually absorb into the body.The physician thought shortly after the dbs surgery there was a small rupture and it gradually built up over the last few months until it pressed on the left-hand side, and it caused the symptoms.

• 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: 15961855
• MDR Text Key: 305337583
• Report Number: 3004209178-2022-16288
• Device Sequence Number: 1
• Product Code: PJS
• UDI-Device Identifier: 00763000519247
• UDI-Public: 00763000519247
• 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: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2023
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2022
• Date Device Manufactured: 04/27/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male