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

Model Number 37612

Device Problem Insufficient Information (3190)

Patient Problems Headache (1880); Muscle Weakness (1967); Muscular Rigidity (1968); Pain (1994); Paralysis (1997); Tinnitus (2103); Visual Impairment (2138); Burning Sensation (2146); Ulcer (2274); Discomfort (2330); Hypoesthesia (2352); Numbness (2415); Shaking/Tremors (2515); Ambulation Difficulties (2544); Paresthesia (4421); Unspecified Nervous System Problem (4426); Increased Sensitivity (4538); Insufficient Information (4580)

Event Date 02/24/2023

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

Information was received from a patient (pt) regarding an implantable neurostimulator (ins).The reason for call was pt reported current ins had some issues that started two days after implant.Pt said implant was at 6.5 v but that setting was way too high and they experienced "high heat in their forehead with odd symptoms", they had lots of noise in ears, their hands felt really hot, they lost feeling their palms of their hands and that had continued.Pt said they still have paralysis in their left hand and some (paralysis) in their right hand.Pt said they have high sensitivity (specifically in palm of hand), a feeling of area getting hot and pain in their hands.Pt said that this pain/sensitivity heat started 2 days after they got the ins.Pt said back then the healthcare provider (hcp) was trying to address tremor in their right hand (from parkinson's).Pt said their "brain heating up" had been a very painful event that they still had pain from.Pt dbs was turned to 2v (during that first programming session 2 days post implant) but their hands never recovered.Pt said managing dbs hcp thought the cause of the issue was caused by a lesion in the brain the pt suffered that somehow caused the burning and sensitivity pt has.Pt said because of this their dbs was now turned off completely.Pt said since dbs had been turned off they have no parkinson's symptoms at all, no tremor, but they still had limited ability in their left hand, almost no dexterity in left hand, fingers were stiff and don't straighten out.Pt said their right hand had experienced numbness but they think that was because of a problem they had with their previous ins.

Manufacturer Narrative

It was previously reported as non-serious injury, after review, the file has been updated to serious injury.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.

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

Additional information received from the consumer reported 48 hours after their surgery they had severe heating of their head, forehead, terrible headaches, noises in their ears that sounded like freight trains,their eyes wouldn¿t track correctly nor would their hands.The symptoms continued for 48 hours until stimulation was turned down from 6v to 2v and the symptoms got better.The consumer then mentioned their battery quit/stopped functioning and was restarted with increased voltage (about two volts) to provide the same therapy.The patient¿s pain and paralysis with increased sensitivity were still present so the dbs device was turned off due to no presence of tremor and the side effects they were experiencing.The consumer continued to say that although the pain in their hands, numbness, and loss of dexterity have continued to increase to the point they currently are (very limited use in the left hand with numbness and tingling), burning of palms on both hands and underside of fingers with the left hand being worse than the right, they underwent testing.The testing included vitamin, mineral deficiency, vitamin injections, nerve conduction tests with ¿fairly normal neuropathic pain in the legs and feet¿ with no real explanation for the loss of use of their hand.According to the consumer they told their neurosurgeon about this who said it ¿sounded like they may have a lesion on their brain¿ as they had some side effects but no longer had a tremor.The consumer stated the neurosurgeon said, ¿when they used to do lesions on purpose, sometimes it would stop the tremor, but side effects would appear like the ones they have.¿ on (b)(6) 2023, stimulation was turned off resulting in no tremors but the side effects didn¿t change.The neurosurgeon also said the hand damage was likely permanent.The patient provided clinic notes from numerous visits with their physician.On (b)(6) 2022, the physician saw the patient and tried to adjust their settings, but it appeared the current settings were the best for the patient.At this time the patient mentioned having severe headaches with higher settings, but they were currently experiencing numbness and a loss of dexterity along with increased tremors, but this could be related to vitamin deficiency.On (b)(6) 2022, the patient saw their physician who noted progressive hand and leg numbness and weakness which was thought to be related to neuropathy (which the patient had for a long time), but was possibly due to vitamin deficiency, however, the patient noted that this started a few days after surgery for replacing the battery and before covid which occurred a week later.The patient noted their hand numbness progressed to above their wrist, weakness in their hands, aching, tingling and burning in the hands, leg numbness which had increased in intensity, dropping items more frequently, and tightness in their hands and legs.At this time the battery was at 75% with normal impedance values.On (b)(6) 2022, the healthcare provider (hcp) saw the patient and noted the patient had some slowness in their left hand which was possibly due to them decreasing stimulation on the left side of their body too low or that they had some contractures in the tendons of the left hand.Stimulation was increased to 2v and the patient was instructed to use it for three weeks to see if there was any improvement in the left-sided stiffness.If no improvement the patient could either increase to 2.5-3v or reduced back to 0.5v on that side (limits ranging from 0-5.2v).Imaging was also performed which showed severe narrowing around the nerve roots at c5-c6, but it was unlikely to be the cause of the neuropathic symptoms (pain).Prior to adjustments being made stimulation was on a very low voltage on both sides with good tremor control.Upon examination the patient did show signs of rigidity, slight tremor, and weakness.On (b)(6) 2023, the healthcare provider (hcp) saw the patient and noted the patient had a deep brain stimulator to treat tremor and dyskinesia, but it ¿sounded like they may have had a lesion in their brain from the power outage that affected their stimulator and led to higher stimulation parameters than usual.It was possible it caused damage to the brain making the dbs less effective.The dbs was turned off and they didn¿t see much change in their presentation.¿ the hcp increased the settings on the left side which they thought reduced some of the slowed movement on that side, however the patient felt more unstable and uncomfortable on that setting.Settings were left at a low voltage on both sides which controlled the tremor well with the battery at 50% and impedances normal.The dbs device was kept off since it was unclear if they were getting any benefit from it.The hcp noted the patient did have pain in their hands, feet, low back, and hips along with neuropathy which they had when the hcp first met them, but these symptoms worsened after getting covid when they were unable to take in much food and experiencing some vitamin deficiencies which likely worsened the neuropathy.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• 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: 16457340
• MDR Text Key: 310424696
• Report Number: 3004209178-2023-02763
• Device Sequence Number: 1
• Product Code: MHY
• 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,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2022
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/07/2023
• Date Device Manufactured: 08/23/2021
• 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 Outcome(s): Other
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 122 KG