Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 37603
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fatigue (1849); Pain (1994); Weakness (2145); Discomfort (2330); Neck Pain (2433); Ambulation Difficulties (2544)
Event Date 11/27/2019
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 37603, serial#: (b)(4), implanted: (b)(6) 2016, product type: implantable neurostimulator.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported on regular occasions the patient has "alarming episodes" she believed to be related to the deep brain stimulation (dbs) device.She has pain that starts at ear level and shoots up her head to the top of the forehead and around the right side.The episodes make the patient very weak and she cannot stand straight.The patients arm gets very sore and tired, too, and the following day she has difficulty eating.The last episode lasted three days, but they usually last one day.The pain was described as a shooting, stabbing pain, and is always in the neck on the right side.The patient described her pain as a 12 on a scale of 1 to 10.She has been hospitalized multiple time as a result of these episodes.The surgeon who implanted the device was consulted, but was allegedly unable to provide insight.The patient was implanted for essential tremor and movement disorders.Refer to manufacturer report #3004209178-2020-14500 for details pertaining to the reportable related event.
 
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.The initial "episode" occurred 2019-11-27, and the patient went to the emergency department.The pain was intermittent, but stimulation was always on and delivering good therapy.A ct scan was performed, but results were not known.The patient was prescribed medication for the pain which helps, but makes her sleepy.An appointment was scheduled for (b)(6) 2020t o investigate the issue, and an impedance check was planned.
 
Event Description
Additional information was received from the manufacturer representative (rep) stating that the results of the impedance check were all good.A ct was performed.It was also indicated that the neurologist thinks it is cervical dystonia.Patient was scheduled for botox injections.
 
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10437188
MDR Text Key203889012
Report Number3004209178-2020-14501
Device Sequence Number1
Product Code MHY
UDI-Device Identifier00613994761071
UDI-Public00613994761071
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
Report Date 10/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date04/28/2018
Device Model Number37603
Device Catalogue Number37603
Was Device Available for Evaluation? No
Date Manufacturer Received10/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age71 YR
Patient Weight70
-
-