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

MAUDE Adverse Event Report: NEURO - VILLALBA 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
 

NEURO - VILLALBA SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97714
Device Problems Unintended Collision (1429); Inappropriate/Inadequate Shock/Stimulation (1574); Impedance Problem (2950); Patient Device Interaction Problem (4001)
Patient Problems Electric Shock (2554); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/09/2021
Event Type  Injury  
Event Description
Information was received from a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use. It was reported that pt said he was getting zingers starting about 3 weeks ago when he changed position in bed. Prior to that things were good.  pt has had multiple falls over the last years. Impedances were checked and electrodes 9-15 were out of range. The patient was reprogrammed not using the 8-15 lead and the issue was resolved.
 
Manufacturer Narrative
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
Manufacturer (Section D)
NEURO - VILLALBA
call box 6001
villalba PR 00766
Manufacturer (Section G)
NEURO - VILLALBA
call box 6001
villalba PR 00766
Manufacturer Contact
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key12918896
MDR Text Key289085470
Report Number6000153-2021-00062
Device Sequence Number1
Product Code LGW
UDI-Device Identifier00643169109483
UDI-Public00643169109483
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 Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 07/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/28/2014
Device Model Number97714
Device Catalogue Number97714
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received07/08/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/13/2014
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: 12/02/2021 Patient Sequence Number: 1
-
-