MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 97714

Device Problem Data Problem (3196)

Patient Problems Pain (1994); Numbness (2415); Ambulation Difficulties (2544)

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 a neurostimulator for unknown indication of use.It was reported that sometimes when patient tried to increase stimulation, the voltage would actually decrease.This issue started sometime last week.She had attempted to reset controller by removing the batteries and replacing them and issue would resolve.During call, patient reset controller and was able to increase stim normally but tried again moments later and issue started again (stim decreased when patient pressed stim increase button).Patient called back to clarify notify and event date.Patient called on (b)(6) 2020 and left a voice-mail as well as a text message reporting the issue she was having with her programmer.Patient not sure if the manufacturer representative still worked with the manufacturer as she never heard back from him.Patient then confirmed that the actual event date for the issue with the programmer was the same day she left a voicemail - (b)(6) 2020.Patient reported 006 code on programmer and that her stim was turned off.Because she thought her stim was off she was "numb and in pretty bad pain already".Every night she turned stim down so she could sleep and then she would turn it back up in the morning when she woke.She tried resetting the programmer by removing the batteries but this did not resolve the 006 code.Technical service specialist (tss) asked the patient to try resetting the controller again during the call and to also press all the buttons on the programmer once before reinserting the battery.Patient did this and confirm issue was then resolved.Patient was able to adjust stim and reported that stim was on.Patient called back and reported about a cracked belt and that when she would turn her device down, it would turn itself back up and that the controller was malfunctioning.She was in pain and can barely walk.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, 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 Key: 10369062
• MDR Text Key: 201895591
• Report Number: 3004209178-2020-13500
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Date Device Manufactured: 06/06/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1