• 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 97702
Device Problems Failure to Deliver Energy (1211); Energy Output Problem (1431); Battery Problem (2885); Electromagnetic Compatibility Problem (2927); Insufficient Information (3190); Patient Device Interaction Problem (4001)
Patient Problem Insufficient Information (4580)
Event Date 10/18/2021
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 patient who was implanted with an implantable neurostimulator (ins) for spinal pain. The reason for call was pt said they cannot feel their stimulation and when they tried to look at their programmer, they did not see the simulation level numbers. Pt mentioned that they knew the stimulation was not working because they usually cannot lay on their spine because the stim "goes crazy" when they lay back but now they can lay on their spine. Pt said they tried changing the batteries in their programmer and that did not resolve the issue. Pt mentioned that they had a procedure last wednesday where a numbing agent and steroids were used on their spinal cord. Pt said their ins was not turned off during the procedure because they forgot to bring their programmer. Pt was unable to further troubleshoot because they could not reach their ins and their aid was not there to assist. Pt said their aid will be there tomorrow and they will call back for further troubleshooting. Pt was very difficult to understand throughout the entire call. Pss believes the pt said their hcp was dr. (b)(6) however, pss was having a very hard time understanding what the pt was saying.  pt called back and said that their aid was there to assist, and they were still not feeling current running from their pain stimulator. Pt said they still show no numbers on their programmer and the aid checked the batteries and put new batteries in it, but implant it still not working. Pt confirmed that they are seeing a doctor screen with eos on the screen. Pt said they haven't felt any currents for at least 4-5 days. Pss redirected pt to speak with their doctor page a mdt rep to check the implant and address the eos. Pss provided pt with nas number for hcp office to call.   pt called back from number registered repeating they reached eos. Pt said their doctor told pt to call to try and meet with a rep at western reserve hospital to try and program their device. Pss reviewed eos information and that pt's device ran out of battery, but pt asked to meet with a rep.
 
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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key12707312
MDR Text Key281847575
Report Number3004209178-2021-16005
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 Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/28/2019
Device Model Number97702
Device Catalogue Number97702
Was Device Available for Evaluation? No
Date Manufacturer Received12/02/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/02/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-