• 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

  • 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 Back to Search Results
Model Number 97714
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/08/2016
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient via healthcare provider who was implanted with an implantable neurostimulator (ins). It was reported that patient did not bring pp as patient had stated to mri tech that the system was turned off and was "no longer working". Discussed that based on implanted components, the system is potentially full body conditional and a depleted ins is considered off per mri guidelines. Mri tech would follow up with implanting hcp to determine implant location, etc. To determine whether system would be full body eligible and decide whether scan based on that information. Further reported that the patient reported that their device never worked for them; they weren't getting relief. As a result of the lack of relief, the patient stopped using their therapy. They stated their doctor told them there wasn't "enough juice" in the ins to target the patient's pain. The patient requested a letter from the manufacturer stating that the ins is in an off state so they could get an mri. They were redirected to their doctor to obtain that letter. Additional information was received from the consumer reporting there was no device concern, just did not work for the patient. Contributing factor was the patient¿s back was too bad as their doctor stated their back was too bad for the system. The cause of the system not working was their back. Another surgery will be performed to resolve the event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSURESCAN
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 Key12362148
MDR Text Key267953659
Report Number3004209178-2021-12858
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 consumer,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/28/2017
Device Model Number97714
Device Catalogue Number97714
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/13/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/28/2016
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: 08/24/2021 Patient Sequence Number: 1
-
-