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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 PARKINS

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MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS Back to Search Results
Model Number 37612
Device Problems Failure to Deliver Energy (1211); Energy Output Problem (1431); Therapy Delivered to Incorrect Body Area (1508); Electromagnetic Compatibility Problem (2927)
Patient Problems Device Overstimulation of Tissue (1991); Pain (1994); Dysphasia (2195); Insufficient Information (4580)
Event Date 04/28/2023
Event Type  malfunction  
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.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 caller reported that the patient dropped a pulse oximeter (a device that is placed on the finger to measure oxygen saturation in the body) on their ins battery, and now the patient is "getting a surge going through his brain stimulator" and "it messed up the brain stimulator.".The caller added, "he turned it off, it's pulsating.He says he can think clearly, but the words that he's trying to say are not translating - not coming through.So it's like a glitch, some type of surge is happening.".Agent could hear the patient in the background stating that the ins was "not even stimulating right now.".The caller stated that the ins was turned off as far as they knew.The caller stated that they called the patient's managing healthcare provider (hcp) , but the hcp's office told the caller that the hcp was out of the office today.The caller was advised to call mdt to request assistance, and if mdt could not help they were instructed to bring the patient to the nearest er.Agent reviewed role of mdt and offered to reach out to the manufacturer representative (rep) via email.Agent also reviewed that the caller could have the patient's hcp office call nas to page their local rep.The patient was redirected to their healthcare provider to further address the issue.
 
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 rep that the hcp called, reporting an oximeter dropped on patient's implant.The patient is having difficulty talking and pain in the face/head area.Rep called the patient who reported overstimulation in the toes and fingers.Rep then asked the assistant to turn patient's therapy on and patient reported not feeling any different.It was unknown how therapy turned off and it's also unexplained on how the patient felt overstimulation in the toes and fingers if therapy was confirmed to be off.Rep will check with patient later to see if symptoms subsides with therapy back on.Additional information was received from the rep that the patient went to the er last week, a ct scan was done and impedance check was done, but no issue was found.Rep said patient now reports feeling pulsing in the feet and hands when therapy is off, but not when therapy is on.Last friday when therapy was turned on, patient said he didn't feel anything different, meaning sensation in hand and feet was still there with ther apy on.Rep to get json reports and mdt data file to look for cause of patient's sensation.Agent advised that the issue is more likely to be medical in nature.Additional information was received from the rep that when the patient was at their appointment yesterday, the hcp did a blind test and patient reported stimulation in hands and feet with therapy off.Agent reviewed that the issue is still likely medical in nature as ins is off.Rep requested further investigation to see if there could be power surges that cause this issue.Agent reviewed it's not likely possible to find such detail in the data files.An engineer reviewed the reports and he was not able to determine any power fluctuations or cause of why patient felt stimulation in his hands and feet when therapy was off.
 
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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 Key16845756
MDR Text Key314306702
Report Number3004209178-2023-05742
Device Sequence Number1
Product Code MHY
UDI-Device Identifier00643169529762
UDI-Public00643169529762
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P960009
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 05/05/2023
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 Date06/28/2016
Device Model Number37612
Device Catalogue Number37612
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/28/2023
Initial Date FDA Received05/01/2023
Supplement Dates Manufacturer Received04/28/2023
Supplement Dates FDA Received05/05/2023
Date Device Manufactured08/13/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age58 YR
Patient SexMale
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