• 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. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

  • 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. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97715
Device Problems Unintended Collision (1429); Energy Output Problem (1431)
Patient Problems Muscular Rigidity (1968); Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Discomfort (2330); Ambulation Difficulties (2544)
Event Date 01/30/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
On (b)(6) 2020, information was received from a patient regarding their implantable neurostimulator (ins).It was reported that patient's therapy may need some adjustment because he is having pain again.Pain has been really bad for the past 4 days.Patient tried to increase stimulation but if he goes higher it would just make his muscle tighten and hard for him to walk.Patient also tried the other groups but that did not help.Patient was redirected to follow up with their hcp.On 2020-june-04, additional information was received from the patient reporting that for the last six to eight months their unit was not doing them any good at all and the patient had a loss of therapeutic effect.They stated it was horrible and they wondered if they should just turn it off.It was reviewed that they had the controller and could use it how they wished.The patient stated that they had tried everything; they had turned it up and down and tried groups a, b and c and they stated that it worked best when stimulation was lower.They stated when stimulation was at.4 to.8 it didn¿t seem to agitate as much.The patient stated that when it was turned up it made their pain worse, and they stated that if they turned it off it didn¿t make much difference.The patient indicated that they had probably had about 9 to 10 falls.The event date was asked but was unknown.No further complications were reported/anticipated.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
INTELLIS
Type of Device
STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key10130230
MDR Text Key195332875
Report Number3004209178-2020-09903
Device Sequence Number1
Product Code LGW
UDI-Device Identifier00643169781702
UDI-Public00643169781702
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 06/08/2020
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 Date04/14/2019
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/04/2020
Initial Date FDA Received06/08/2020
Date Device Manufactured04/15/2018
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 Age81 YR
-
-