• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO 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 MED REL MEDTRONIC PUERTO RICO SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97714
Device Problems Unintended Collision (1429); Battery Problem (2885); Charging Problem (2892)
Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)
Event Date 08/01/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The consumer reported that the implant runs out so fast he was charging every two days since three months ago. The patient stated he has not changed the settings or been recently reprogrammed. The patient did note he had a few falls but wasn¿t sure when. The patient was directed to follow-up with a healthcare provider to have the system checked. The indications for use were spinal stenosis and non-malignant pain. No patient symptoms reported.
 
Manufacturer Narrative
Product id: 37791, serial# unknown, product type: recharger. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received and it was reported that the patient wasn't getting coupling bars on the recharger screen. They repositioned 19 times that day and they were able to charge the implant fine 2 days prior. The ins charge level only lasted for 2-3 days, so they had to charge often. The patient stated they had a lot of trauma. The recharger showed the reposition antenna icon screen. No further complications were reported or anticipated.
 
Manufacturer Narrative
Concomitant medical products: product id: 37791, product type: recharger. If information is provided in the future, a supplemental report will be issued.
 
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 MED REL MEDTRONIC PUERTO RICO
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key8258600
MDR Text Key133524198
Report Number3004209178-2019-01249
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
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2014
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 Received02/19/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/12/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-