• 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 Failure to Interrogate (1332); Communication or Transmission Problem (2896); Insufficient Information (3190)
Patient Problems Diarrhea (1811); Fall (1848); Incontinence (1928); Urinary Retention (2119); Numbness (2415)
Event Date 05/17/2021
Event Type  Malfunction  
Manufacturer Narrative

Concomitant medical products: product id 97745 lot# serial# (b)(4) implanted: explanted: product type programmer, patient. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for non-malignant pain. The reason for call was pt said they were trying to get an mri, but only got no device found when trying to access mri mode, and the date/time were wrong on lock screen. Pss asked if the implant was depleted, pt said the implant was at 40% last night when they checked (unknown if implant was depleted). Pt said all they brought to the mri was their controller. Pss had pt reset controller, and after reset pt tried to unlock (first reported the date/time were wrong) but got no device found. The issue was not resolved. Pss reviewed pt would not be able to put their device into mri mode as pt did not have the rtm to try and charge the implant. Pt gave doctor as dr. Ifechi (doctor on file), but pt did not live in mn anymore. Pt mentioned they would probably just have the implant taken out as they had nothing but problems with it (see related cases (b)(4) and (b)(4)). Patient also reported said they would probably have the ins taken out as they have had nothing but problems with it. Pss asked, pt said since implant they would keep losing bowel control and pt was retaining urine. Pss documenting information given during the call. Pt gave doctor as dr. Ifechi (doctor on file), but pt did not live in mn anymore. Patient said starting about a month ago, their legs would keep going numb and pt would keep falling.

 
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 Key11942590
MDR Text Key267139729
Report Number3004209178-2021-08889
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,Followup
Report Date 09/21/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/04/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/14/2020
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 Received09/16/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured09/23/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-