• 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); Therapy Delivered to Incorrect Body Area (1508)
Patient Problems Undesired Nerve Stimulation (1980); Therapeutic Response, Decreased (2271)
Event Date 07/22/2020
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: 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
Information was received from a consumer via a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator (ins).It was reported that the patient had a fall in (b)(6) 2020 and then decreased effectiveness of stimulation for their pain.The rep mapped the leads and electrodes 8-15 needed strong amplitudes for the patient to feel stimulation, and the stimulation was only in the feet.The rep checked impedances and all electrodes were normal.The patient's doctor ordered an x-ray to see if there was a lead migration.The issue was not resolved at the time of the report.
 
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 Key10323774
MDR Text Key200377338
Report Number3004209178-2020-12834
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 company representative,consum
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 07/24/2020
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 Date08/28/2019
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/22/2020
Initial Date FDA Received07/24/2020
Date Device Manufactured09/12/2018
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 Age74 YR
-
-