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 NEUROMODULATION ACTIVA DEEP BRAIN STIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED
  • 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 NEUROMODULATION ACTIVA DEEP BRAIN STIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED Back to Search Results
Model Number 3387S-40
Device Problems Loose or Intermittent Connection (1371); Nonstandard Device (1420); Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problems Headache (1880); Swelling (2091)
Event Date 05/01/2016
Event Type  Injury  
Event Description
On (b)(6) 2016, the patient stated that a wire came loose on the stimulator device and gave him a bright shock to the head.The patient called medtronics to discuss the issue and they simply referred him to a list of doctors.In order 2016, the patient had a minor car accident as well as tremors that resurfaced due to medical malpractice from a prior surgery that he was talked into to address swelling in his legs and feet as well as headaches.In (b)(6) 2016, the patient states that he visited the neurologist that did not relay to him that the stimulator was no longer working.The patient then met with the medtronic surgeon in (b)(6) 2017.The patient states that some time after the meeting he discovered information through his daughter that there was an open recall on his device a month prior to it being implanted in him.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ACTIVA DEEP BRAIN STIMULATOR
Type of Device
STIMULATOR, ELECTRICAL, IMPLANTED
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
minneapolis MN
MDR Report Key7380835
MDR Text Key104023858
Report NumberMW5076196
Device Sequence Number1
Product Code MRU
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 03/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number3387S-40
Device Catalogue Number37612
Is the Reporter a Health Professional? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age57 YR
Patient Weight68
-
-