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

Model Number 37601

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885)

Patient Problems Fall (1848); Numbness (2415); Loss of consciousness (2418); Electric Shock (2554); Paresthesia (4421); Insufficient Information (4580)

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 about a year after they had their rechargeable ins implanted, they had a funny feeling in their head and felt tingling every once in a while after their doctor increased therapy settings.The patient noted thatit felt like a little numbness, and the tingling was in the back of their neck.The patient noted that these sensations were not constant.The patient mentioned that their doctor increased therapy settings every 3 months to help manage the patient's shaking, and they told the patient that the therapy settings were as high as they could go.Additional information received from the consumer reported they got the implant for extreme tremor and possible parkinson's as they were shaking and falling down a lot.After the dbs device, they weren't shaking as much, but they were falling down a lot.The consumer always had that kind of faint numbness in their head since first getting the dbs device.When the ins depleted they felt like they were dying because they felt like they were being electrocuted which was a horrible feeling and they had passed out.When they woke up, they felt good, and for the past year, they had felt that way where they were perfectly like they were before prior to having symptoms (falling down and shaking) that made them eligible for dbs and they did not know what had happened in the years they had dbs, but they no longer had shaking or anything and weren't falling down anymore.

• 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: 16581250
• MDR Text Key: 311669660
• Report Number: 3004209178-2023-03778
• Device Sequence Number: 1
• Product Code: PJS
• UDI-Device Identifier: 00643169529786
• UDI-Public: 00643169529786
• 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: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2017
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/16/2023
• Date Device Manufactured: 01/21/2016
• 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): Other
• Patient Sex: Female