• 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. SURESCAN 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. SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97714
Device Problems Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017); Battery Problem (2885); Insufficient Information (3190)
Patient Problem Device Overstimulation of Tissue (1991)
Event Date 04/16/2021
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 healthcare provider (hcp) regarding a patient who was implanted with an implantable neurostimulator (ins). The reason for call was patient needed mri of lower back but patient wasn't able to get into mri mode because device was possibly in over discharge. Patient hadn't used or charged device for three (3) years because it made patient's leg go wild, patient said she didn't know why this was, patient said device probably shifted and was speculating why device caused her leg to 'go crazy'. Patient said she had always felt the stimulation strongly in the right leg but it had just gotten worse and worse, especially when it was fully charged, the implant made patient feel like her leg was battery operated. The patient was redirected to their healthcare provider to further address the issue. Patient said she see's pain management hcp in fl and this hcp had prescribed the mri. Reviewed option of jump starting implant to place into mri/ mri eligibility sheet. Patient's previous hcp for her device was in (b)(6), patient no longer lived in co and now lived in fl and didn't like the hcp in co and said she didn't want to reach out to him. When asked if the mri of the low back was device related the patient said "i am having a lot of pain and they are looking at injections, i told my hcp that we need to get the implant out because i'm not using it". Patient said the previous managing hcp told her that the implant was never good anyways, patient said she didn't know what happened but hcp didn't tell patient that until she needed another injection. Caller reported patient was in mri center earlier, got her product charged up and cannot access mri mode. Patient is no longer at the center.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSURESCAN
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 Key11694901
MDR Text Key249682967
Report Number3004209178-2021-06347
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 health professional
Reporter Occupation
Type of Report Initial
Report Date 04/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/14/2017
Device Model Number97714
Device Catalogue Number97714
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/16/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/15/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-