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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 37603
Device Problems Energy Output Problem (1431); Battery Problem (2885)
Patient Problems Nausea (1970); Device Overstimulation of Tissue (1991); Distress (2329); Depression (2361); Shaking/Tremors (2515); Convulsion/Seizure (4406); Insufficient Information (4580)
Event Date 11/03/2020
Event Type  Injury  
Manufacturer Narrative
The event date is an estimated date.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported they are seeing elective replacement indicator (eri) on their programmer.They mentioned that their tremors have been getting really bad again for the past 3 or 4 weeks.They have been under a lot of stress lately and believes that could have caused the tremors to come back again.Their tremors have been so bad that their arms and hands will jump badly at night, so they have been unable to turn the implant off when they sleep like they used to and that has drained the implant battery quicker.They are on group c at 3.30v.They cannot put the settings any higher because if they do, they will get nauseous.If they puts them any lower, the tremors get even worse.They stated that they have ptsd because when their tremors get bad again, it causes them to get depressed, which then causes them to have seizures, like a domino effect.They were redirected to their healthcare provider (hcp) to further address the issue.
 
Event Description
The patient called back and said the ins was dead.She is having the ins replaced on (b)(6) 2020.Due to the ins being dead, she was bouncing off the walls and sick to her stomach.
 
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.
 
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.
 
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 was received from the consumer adding that their right hand was shaking really bad and they felt nauseous when the ins settings were "too high" on group d at 3.20.The manufacturer representative (rep) showed the patient how to check the ins voltage with their programmer.The physician replaced the ins but they continued to feel nausea because the ins settings remained at a level that is too high.They added that the ins battery lasted three years, which they attributed to the ins settings and their stress level.Refer to manufacturer report #3004209178-2021-02782 for related device.
 
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Brand Name
ACTIVA
Type of Device
STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
MDR Report Key10938917
MDR Text Key219330569
Report Number3004209178-2020-21051
Device Sequence Number1
Product Code MHY
UDI-Device Identifier00613994761088
UDI-Public00613994761088
Combination Product (y/n)N
PMA/PMN Number
P960009
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup,Followup
Report Date 02/17/2021
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 Date01/28/2019
Device Model Number37603
Device Catalogue Number37603
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/01/2020
Initial Date FDA Received12/03/2020
Supplement Dates Manufacturer Received12/02/2020
12/21/2020
02/12/2021
Supplement Dates FDA Received12/05/2020
12/23/2020
02/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age71 YR
Patient Weight76
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