• 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

  • 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 Back to Search Results
Model Number 97715
Device Problems Disconnection (1171); Energy Output Problem (1431)
Patient Problems Headache (1880); Malaise (2359); Cognitive Changes (2551); Insufficient Information (4580)
Event Date 01/01/2021
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 patient (pt) regarding an implantable neurostimulator (ins). The reason for call was starting about 3 weeks ago or more the pt noticed that their stimulation was not working on their right side. Pt stated that they have received bad headaches that are "killing" them, making them sick and they have a hard time thinking because of the lack of therapy.  the caller was redirected to their manufacturing representative (rep). Emailed reps regarding pt's therapy. Additional information was received from a manufacturer representative (rep). It was reported that the patient had an appointment to be seen in clinic on thursday (b)(6) 2021. Additional information was received from a manufacturer representative (rep). It was reported that the patient was reprogrammed and coverage was restored. The cause of the event was not determined. Additional information was reported that the patient had consistent headaches which started six or seven months ago (patient services specialist did not clarify year). Then, four to five months ago (pt also mentioned "a few months") pt stopped receiving therapy on right side; pt turned up therapy, but still did not get therapeutic relief. Yesterday, the pt had an appointment with health care provider (hcp) for injections to address back pain and numbness in arm related to arthritis, and hcp told pt one lead was disconnected from ins and was "floating. " hcp directed pt to call a manufacturing representative (rep) to see if pt could get any therapeutic relief. The patient was redirected to their healthcare provider to further address the issue. Pt mentioned they had high blood pressure when they saw their hcp yesterday and mentioned they do not want to have surgery again. Pt also mentioned having routine adjustments with mdt rep (name, asked/unknown) shortly after implant date.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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 Key12108167
MDR Text Key259689544
Report Number3004209178-2021-10319
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 07/02/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/02/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/14/2021
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 Received07/01/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured09/14/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-