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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

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ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS Back to Search Results
Model Number 37612
Device Problems Unintended Collision (1429); Low impedance (2285); Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/28/2021
Event Type  Injury  
Manufacturer Narrative
Other relevant device(s) are: product id: 3708660, serial/lot #: (b)(4), ubd: 24-may-2023, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported there was low impedance between contact 9 and 10.The patient had fallen several times, which may have contributed to the issue.No troubleshooting was performed.The issue was not resolved at the time of the report.Additional information was received indicating the cause of the issue was due to the patient falls and their care.There was an issue with the extension as it was defective and the extension was replaced.After the replacement, all of the impedances were within normal range.
 
Event Description
Additional information was received: it was reported that they believed the extension was damaged.
 
Manufacturer Narrative
Section d information references the main component of the system and other applicable components are: product id 3708660 lot# serial# (b)(6) explanted: (b)(6)2021 product type extension product id 3389-28 lot# unknown serial# implanted: 2019-09-12 product type lead product id 3708660 lot# serial# (b)(6) explanted: (b)(6)2021 product type extension 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
Section d information references the main component of the system and other applicable components are: product id: 3708660, serial# (b)(6), explanted: (b)(6) 2021, product type: extension; 3708660, serial# (b)(6), explanted: (b)(6) 2021, product type: extension.H3: analysis of the extension could not be performed as patient consent for analysis was not received.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.
 
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Brand Name
ACTIVA
Type of Device
STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
MDR Report Key12294658
MDR Text Key265610063
Report Number2182207-2021-01378
Device Sequence Number1
Product Code MHY
Combination Product (y/n)N
PMA/PMN Number
P960009
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 11/01/2021
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 Model Number37612
Device Catalogue Number37612
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/28/2021
Initial Date FDA Received08/09/2021
Supplement Dates Manufacturer Received08/10/2021
11/01/2021
Supplement Dates FDA Received08/13/2021
11/01/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
"SEE H10...."
Patient Outcome(s) Required Intervention;
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