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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 37612
Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Foreign Body Reaction (1868); Skin Erosion (2075)
Event Date 09/29/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 3708660, serial #: (b)(4), product: type extension.Product id: 3708660, serial #: (b)(4), product: type extension.Other relevant device(s) are: product id: 3708660, serial/lot #: (b)(4), ubd: 13-jun-2020, udi#: (b)(4).Product id: 3708660, serial/lot #: (b)(4), ubd: 10-jun-2020, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider (hcp) of a clinical study regarding a patient with an implantable neurostimulator (ins).It was reported the patient had a reaction to a foreign body.The issue was ongoing.Exposure of the extensions of the stimulation device was observed, with eroded skin in the right retromastoid region, no secretion.It was reported there was migration of the extension.The hcp did not change cables.The event resulted in an urgent care visit and in-patient hospitalization.The area was washed, debrided, flapped, and sutured.The output of the neurostimulator leads in the right retro-auricular region were examined.The issue was determined to be related to the device or therapy.It was not related to the implant procedure.No further complications were reported or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received stating the event was still ongoing as of (b)(6) 2019.
 
Manufacturer Narrative
Product id: 3708660, serial# (b)(4), product type: extension; product id: 3708660, serial# (b)(4), product type: extension.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the hcp changing the clinical diagnosis from "reaction to foreign body" to "eroded skin".
 
Manufacturer Narrative
Product id: 3708660, serial# (b)(4), product type: extension; product id: 3708660, serial# (b)(4), product type: extension.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from an hcp of a clinical study via a rep indicated the extensions were replaced on (b)(6) 2019.The issue was resolved at the time of the report.
 
Event Description
Additional information was received: it was reported that there was exposure of the extensions and the battery to the outside of the skin of the scalp and subclavicular region, along with extension migration.The devices were explanted without replacement and the issue was said to have resolved without sequelae on (b)(6) 2021.
 
Manufacturer Narrative
Continuation of d10: product id 3708660; serial# (b)(6); explanted: (b)(6) 2021; product type extension; product id 3708660; 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.
 
Event Description
Additional information was received: it was reported that the extensions had migrated outside the skin of the scalp and the subclavicular region respectively due to a foreign body reaction, not damage to the neurostimulator.The extensions were removed and discarded on (b)(6) 2021.
 
Manufacturer Narrative
Continuation of d10: product id 3708660 lot# serial# (b)(6) explanted: (b)(6) 2021 product type extension 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.
 
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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
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 Key8281800
MDR Text Key134223890
Report Number3004209178-2019-01827
Device Sequence Number1
Product Code MHY
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
P960009
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 01/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/14/2017
Device Model Number37612
Device Catalogue Number37612
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/29/2021
Date Device Manufactured07/20/2016
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) Hospitalization;
Patient Age67 YR
Patient Weight60 KG
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