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 Headache (1880); Visual Disturbances (2140); Ambulation Difficulties (2544); Insufficient Information (4580)

Event Date 08/11/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: b3301542m, serial# (b)(4), implanted: (b)(6) 2021, product type: lead, product id: b3301542, serial# (b)(4), implanted: (b)(6) 2021, product type: lead.Other relevant device(s) are: product id: b3301542m, serial/lot #: (b)(4), ubd: 28-apr-2023, udi#: (b)(4); product id: b3301542, serial/lot #: (b)(4), ubd: 25-aug-2023, 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 Description

It was reported that when patient (pt) had the "original" implant surgery, they had a second mri and were told that one lead on the left side of their head was "a little too close to where it should be," which they were told was the reason the patient had side effects from the ins.Regarding the side effects, the patient stated that whenever the ins was turned on their gait was off, it affected their vision, and they were "like a zombie." the patient stated that all those side effects went away within 5 minutes of turning therapy off, but they would come back when therapy was on.The patient then stated that during their second implant surgery, the second lead was implanted in the wrong place (while they were awake), so it had to be explanted and reimplanted after the surgeon mapped where they wanted to implant it.After the lead was reimplanted, the patient said they instantly got really severe headaches "when they turned that side on" and felt like their head was going to explode, which made the patient think they were having a stroke.However, surgeon told the patient that they thought the reason for the headaches was because they possibly hit a nerve during the surgery, but there was no way of confirming that.The patient added that their head hurt so bad after that surgery that they had to put their head on ice for days.Ever since the second implant surgery, the patient stated that hey suddenly start getting headaches about 2 days after they turn therapy on, noting that the headaches get worse and turn into almost a migraine.The patient stated that the headaches clear up in 2-3 days after they turn therapy off, and the headaches do not come back as long as therapy remains off.The patient stated that their doctors keep trying to tell them that the headaches and side effects were not related to the ins, but the patient knows they are since the headaches and side effects go away when therapy is off.The patient mentioned that their doctors have had trouble programming the ins for almost 6 months now, and told the patient there was nothing more they could do.The patient stated that their doctors told them they could leave the ins implanted or have it removed.The patient stated that their reason for calling was to find out if there was another doctor they could get a second opinion from.Agent emailed physician listings to the patient and redirected them to their healthcare provider to further address the issue.The issue was not resolved.

• 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: 15103821
• MDR Text Key: 304594210
• Report Number: 3004209178-2022-09475
• Device Sequence Number: 1
• Product Code: PJS
• UDI-Device Identifier: 00763000384357
• UDI-Public: 00763000384357
• 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: 07/26/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2022
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/21/2022
• Initial Date FDA Received: 07/26/2022
• Date Device Manufactured: 06/23/2021
• 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: 70 YR
• Patient Sex: Male