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

Model Number 37601

Device Problems Migration or Expulsion of Device (1395); Unintended Collision (1429)

Patient Problems Fall (1848); Neuropathy (1983); Dysphasia (2195); Ambulation Difficulties (2544); Confusion/ Disorientation (2553)

Event Date 01/23/2023

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 3387s-40 lot# (b)(4) serial# implanted: (b)(6) 2019 product type lead product id 3387s-40 lot# (b)(4) serial# implanted: (b)(6) 2019 product type lead product id 3387s-40 lot# (b)(4) serial# implanted: (b)(6) 2019 product type lead.Other relevant device(s) are: product id: 3387s-40, serial/lot #: (b)(4), ubd: 14-may-2021, udi#: (b)(4); product id: 3387s-40, serial/lot #: (b)(4), ubd: 14-may-2021, 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

Information was received from a patient's representative regarding an implantable neurostimulator (ins).The reason for call was caller reported that the patient had severe neuropathy in their legs and feet so they used a walker, and in the last couple of weeks the patient had fallen 4 times, and on thursday night, the patient started saying odd things and the patient had been confused, as well as the patient's balance and other things had been really off, which the caller stated could happen with the patient's neuropathy, but the caller was concerned that potentially the patient's lead or something with the dbs system could have come loose from the patient's falls that could be the cause of the patient's symptoms.The caller stated the patient since thursday had been in the hospital.The hospital believed the patient was having stroke, however, stroke was ruled out and the patient had no blood clots or bleeding.The caller stated cat scans had been performed and the providers would like to do an mri, but they had been unable to get ahold of the patient's follow-up healthcare provider (hcp) at sanford hospital due to being out of office.

• 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: 16237243
• MDR Text Key: 308045702
• Report Number: 3004209178-2023-01025
• Device Sequence Number: 1
• Product Code: PJS
• UDI-Device Identifier: 00643169864191
• UDI-Public: 00643169864191
• 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: 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2020
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/23/2023
• Date Device Manufactured: 10/31/2018
• 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 Outcome(s): Hospitalization
• Patient Age: 79 YR
• Patient Sex: Male