• 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 Impedance Problem (2950); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Muscle Spasm(s) (1966); Pain (1994); Therapeutic Effects, Unexpected (2099); Sleep Dysfunction (2517)
Event Date 04/26/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer concerning patient with an implantable neurostimulator (ins). It was reported the patient was setting settings not available on the controller. The patient was getting this message only on group b. The patient states she uses this setting 90% of the time. The patient reported she has not been able to sleep the last couple nights. The patient was in pain and spasms in her left leg. The patient states she can use group a and c and can increase but they do not help her with the left leg, which she needs. While on the call the patient decreased down to zero and could only increase up to 0. 1v before seeing settings not available. The patient also mentioned she has lost 100 pounds. The patient was redirected to their healthcare provider (hcp). No further complications were reported/anticipated. Additional information was received from the patient. It was reported that the "b" setting and main settings stopped working and showing unable to provide stimulation. Patient took out battery and turned b down to 1 and up again however received same message. Patient stated a and c were fine just not providing therapy where she needed. Patient unsure what circumstances may have led to issues however provided that they had gastric sleeve done (b)(6) 2019, and a serious fall with complications then lost over 100 lbs. Patient stated the issue was resolved after meeting with their rep. Patient reported the rep found "2 leads (electrodes) not working" and programmed around them. Patient expressed appreciation. Issue was now resolved.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameINTELLIS
Type of DeviceSTIMULATOR, 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 Key10106797
MDR Text Key193742482
Report Number3004209178-2020-09490
Device Sequence Number1
Product Code LGW
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
Type of Report Initial
Report Date 06/01/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/28/2019
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/26/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/10/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-