• 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 Difficult to Insert (1316); Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009); Insufficient Information (3190)
Patient Problems Therapeutic Effects, Unexpected (2099); Stenosis (2263); Inadequate Pain Relief (2388)
Event Date 01/15/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received by a manufacturing representative (rep) regarding a patient with an implantable neurostimulator (ins) for chronic low back pain and spinal pain. Information was reported that the rep stated the patient has had changes in their scoliosis over the past year that had led to them needing a revision. The rep stated these changes have led to a lack of coverage. No further complications were reported. No additional patient symptoms were reported.
 
Manufacturer Narrative
Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2018, product type: lead; product id: 977a260, serial# (b)(4), implanted: (b)(6) 2018, product type: lead. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the manufacturer representative (rep) 2019-10-11. It was reported that the cause of the patient¿s lack of coverage was due to her scoliotic changes which caused the leads to shift downward. Lead revision as attempted on (b)(6) 2019 but the healthcare provider (hcp) encountered severe stenosis each time he tried to pass lead or stylet guide wire, so the procedure was aborted, and the patient would be brought back for a laminotomy procedure. The issues have not resolved, and the next procedure was not scheduled. The patient¿s weight was unknown. No further complications were reported/anticipated.
 
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 Key9176457
MDR Text Key162006859
Report Number3004209178-2019-19418
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 company representative,consum
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/28/2018
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 Received09/20/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/06/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/10/2019 Patient Sequence Number: 1
-
-